Understanding supplier management for medical devices

The problem with a supplier management program lies in the fact that the FDA audits suppliers only for finished devices. Because of this, manufacturers need to have a high degree of control over them. So, where is the problem? It lies in the FDA’s interpretation of these expectations. This keeps changing from time to time. Over the past five years, these expectations have changed considerably. Manufacturers whose devices have been around for more than five years need to thus make substantial changes into their cGMPs, hence the emphasis on the ‘c’, meaning “current”. A seminar from the guru of supplier management The underlying principles of supplier management will be the basis for a two-day seminar that is being organized by GlobalCompliancePanel, a reputable provider of professional trainings for the areas of regulatory compliance. The Director of this course, Betty Lane, who is the founder and President of Be Quality Associates, LLC, a consulting company that helps small and medium sized medical device and diagnostic companies implement and improve their Quality Systems, will be the Director of this seminar. To enroll for this very valuable learning session, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900595SEMINAR?medical-device-manufacturers-Switzerland. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. Analogous to the FDA’s thinking, European Notified Bodies also periodically update their expectations. Suppliers are now expected to remain current with a guidance document published by the Notified Body Operations Group (NBOG). This seminar will explore the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation on supplier management by expanding on them to cover other issues and techniques important in effective implementation. Tools, templates and methods of supplier management Betty will familiarize participants with the nitty gritty of supplier management by building upon it with the tools, templates, and methods needed for implementing an effective and efficient supplier management program. These tools consist of practical exercises which the Director will get the participants to perform. She will also use FDA Warning Letters to illustrate the points and help the participants learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers’ location, supplier auditing techniques, and supplier issues in management review. These practical steps are aimed at fortifying and reinforcing their understanding of the topic. It will also offer the kind of interactivity with which the participants can understand the concepts threadbare. The insight the Director will be offering into the area of supplier management will be the highlight of this seminar. This has been accumulated over years and years of experience that the Director has gained in the area of supplier management in medical devices. The Director will detail and examine the concept of risk from the perspective of both the supplier and the regulatory bodies with depth and clarity. She will also review requirements and expectations of the FDA and European Notified Bodies for supplier management, and then show how to incorporate these into the participants’ own supplier management process.

Amazing Images of Inside San Joe Mine

Chile’s 33 trapped miners who have become global stars were rescued after over two months trapped deep beneath the earth. Their longest underground nightmare in history ended safely. Miners were raised one by one through a smooth-walled shaft of rock. The rescue which exceeded expectations every step of the way was planned with extreme care. The rescue operation has been so marvelous, clean, and emotional.

 

32 Chileans and one Bolivian had to suffer from coldness and darkness before their miracle escape. Inside San Joe Mine was hellish and dank. 33 miners had to live there for 69 days. The following astonishing pictures which were taken by the Chilean Navy sent to save 33 trapped Chilean miners highlight the cold and dark reality.

 

The 33 miners made a pact of silence.

 

Rescued miner Victoria Segovia took notes which could become a manuscript about the experience. The miners had an outline with 33 chapters based on the log that Victoria kept. Segovia’s anxiety made him forget the notebook down below and had it brought up by one of his companions.

 

Raul Bustos was assessed by a medic while waiting his turn to be lifted to the surface of the San Jose mine.

 

Miner Edison Pena was assessed by a medic while waiting his turn to escape.

 

Miners waited patiently to be rescued.

 

Miner Carlos Mamani received the sacraments at the San Jose mine near Copiapo.

 

Mario Gomez, aged 63, is the oldest of the miners.

 

Miner Luis Urzua at the San Jose mine

On August 5, a cave-in left 33 miners trapped nearly half a mile underground in a small copper and gold mine near Copiapo. September 24 marked 50 days of the miners trapped underground. On October 4, President Pinera said that a rescue was “very close” and expected to have the men out before October 15.

 

 

Related links:

Chile Rejoices as 33 miners are rescued

Chilean Miners Rescued after 69 Days Underground

Chile Celebrates World\’s Longest Mine Rescue as Last Man Freed

Bright Futures Start With Medical Assistant Programs

If you’re looking for a satisfying career in the health care field, you may want to consider working as a medical assistant. Medical assistant programs are widely available at many colleges and can cover a broad range of health related vocations. According to the United States Department of Labor, the occupational outlook of this career choice is expected to grow exponentially and surpass many other career choices.

Medical assistant programs will train you to work in a variety of medical fields such as pediatrics, ophthalmology, podiatry and dentistry, to name only a few. A well trained student who has graduated from an accredited medical assistant program has the potential to move on to other career advancing training programs within the same field. These advanced medical assistant programs provide for higher level training which can mean higher pay and broader employment opportunities in more specialized fields. Upon successful completion of your training program, new medical assistants may find work in medical clinics, doctor’s offices, hospitals or nursing homes.

Duties will vary depending upon your choice of certification or degree level. Administrative medical assistants perform duties specific to office needs. These may include filing insurance forms, making appointments, patient contact and billing needs. The duties of a clinical medical assistant cover a wide range of tasks and may require more patient interaction. These duties may include instructing patients in the proper use of their medications, communicating with pharmacies, wound care, exam room preparation and upkeep as well as working with laboratory samples and tests. This career choice may require certain state regulatory requirements in order to perform some of these specific duties.

If you prefer a more challenging career choice within this field, consider medical assistant programs that concentrate on specialized training. Medical assistants working in the fields of optometry or podiatry, for example, provide rewarding choices for those who prefer a more extensive career option. Ophthalmic medical assistants enjoy a wide range of duties assisting optometrists in providing eye care for their patients. They guide patients in the correct use of their medications and contact lenses, provide chair-side assistance to the doctors, maintain the medical exam rooms and related equipment and provide other necessary tasks as directed by the physician.

Podiatry assistants may make castings of feet, measure feet for shoe inserts, apply medical wraps and may provide surgical assistance. Proper training from an accredited medical assistant program is essential. Many colleges and trade schools provide excellent instruction for students interested in this fulfilling career. Working in this field can also lead to other, more challenging opportunities within the medical profession. As a stepping stone, if you aim for a more advanced medical occupation as a nurse, physician’s assistant or doctor, starting work as a medical assistant is an excellent choice.

Providing you with real world work experience in a medical setting, while earning a salary, is an important aspect of ongoing training. While beginning medical assistant programs often do not require work experience as a prerequisite, some work experience can count as class credits in many advanced medical training programs. Whether looking for a career as a medical assistant, or of you are interested in advanced careers within the heath care field, medical assistant programs provide excellent options for career advancement, job security and a positive occupational future.

Comprehensive risk management is a must for medical device software

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons: 1.Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible; 2.Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps useless and redundant; making it necessary to start from the beginning, no matter at what stage an anomaly is discovered. Embedding software risk management into the bigger scope of overall risk management is the way forward if these fiascos have to be avoided. Learn the ways of doing it right from start till finish The proper ways of how to take all the necessary steps for designing, implementing and testing critical medical device software in a regulatory compliant environment will be the learning a two-day, live seminar being organized by GlobalCompliancePanel, a very respected provider of professional trainings for the regulatory compliance areas. Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, will be the course Director. To participate in this very important seminar, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900681SEMINAR?risk-management-medical-devices-Boston-MA. In line with globally applicable standard requirements International consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, has led to risk management being a mandatory component of almost any activity in the medical device industry. This course will explain these requirements. Given that software risk management has to be embedded into the bigger scope of overall risk management; Markus will introduce all the steps necessary to design, implement and test critical medical device software in a regulatory compliant environment while adhering to the principles of risk management. In addition, he will also address the system level risk management and the resulting interfaces to software. Understanding safety assurance cases The ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place to comprehensively summarize all risk related activities and to demonstrate the safe properties of a device. Currently only required for FDA infusion pump submissions; this documentation will most likely become mandatory for all devices. This course will introduce the basic concepts and content of safety assurance cases and will illustrate their usefulness for internal and external review of safety related information. This seminar will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. It will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. The concept of an assurance case will be introduced to make the combined effort towards designing, implementing and verifying a safe device transparent. The outcome of this learning is that it will help to comply with regulatory requirements with minimized overhead and resource burden.

Different Types of Surgical Scissors

This article explains the different kinds of surgical scissors for the Operating Room. Surgical Scissors like Tenotomy Scissors, Westcott Scissors, iris scissors, etc.

Medical Instrument: Cherry Scissors Use: Cutting Other Details: Commonly regular in brain surgery.

Medical Instrument: Cottle Angular Scissors A.K.A.: None Use: To cut Other Details: For cutting inside the nasal cavity.

Medical Instrument: Facelift Scissors Use: Cutting Other Details: Is used mainly used OR’s to cut tissue in cosmetic surgical procedures, this could include facelifts.

Medical Instrument: Hagar Scissors/Needle Holder Use: Cutting/Suturing Other Details: Used to suture then slice the thread w/o changing instruments.

Medical Instrument: Iris Scissor Use: Cutting/Suturing Other Details: Tiny surgical scissors Used for to slice tissue.

Medical Instrument: Jorgenson Scissors Use: Cutting and Suturing Other Details: Curved GYN scissors used during hysterectomies.

Medical Instrument: Knight Scissors Use: To cut Other Details: Used for suture inside the nasal cavitity. Also for cutting tissue.

Medical Instrument: Littler Scissors Use: To cut Other Details: Tiny tissue surgical scissors for suture passing.

Medical Instruments: Curved Mayo Scissors Alias: Curved Mayos Other Details: Much larger than Metz can be used to slice tissue.

Medical Instrument: Mayo Scissors Alias: Suture Scissors Other Details: Multi-function scissor, most often used for slicing suture.

Medical Instrument: Metzenbaum Surgical Scissors Use: To cut Other Details: Primarily to slice tissue.

Medical Instrument: Potts Scissors Use: To cut Other Details: Before the preparation of the gaft. It’s used to cut the shaft of the blood vessel.

Medical Instrument: Sinus Scissors Use: Cutting Other Details: Frequently slices the tissue inside the sinus cavity.

Medical Instrument: Statinsky Scissors Use: To cut Other Details: Vascualr scissors for large chest.

Medical Instrument: Stevens Tenotomy Scissors Use: Cutting Other Details: Small dissection surgical scissors, very sharp & fine.

Medical Instrument: Tenotomy Scissors Use: To cut Other Details: Used for dissection, also has a fine razor-edged

Medical Instrument: Westcott Scissors Use: To cut Other Details: Primarily used for surgery of the face. These scissors are delicate.

Searching for Surgical Instruments Kinda of like Iris Scissors? Then come visit HNM Medical online Now!

A “The Different Types of Surgical Scissors” editorial is by Mathew T.

Get Benefits by an Appointment with Online medical Consultation

In recent years, the use of internet has increased. Everyone has busy life schedule and people want to get everything at their door. They want everything to do with a click of mouse. Online medical consultation is great boon for these types of people. Online health advice is quite effective and convenient. Online doctor consultation is not a complete alternative for personal medical treatment, but it does give several benefits to the patient over visiting the doctor’s clinic.

These days people are aware about their health and figure. They want to have more and more informations and counseling on the subject of their particular medical issues but do not have sufficient time to go for a doctor’s clinic since they have to devote considerable amount of time in giving a personal visit to doctor’s clinic. Online medical help is best for these types of people. It also provides facility to chat with a doctor online. With online medical consultation, you will be able to get major useful specialty information, which normally a person is trying to seek with ease and at his or her own comfort, without any need for waiting in consultation room to have a meeting with the doctor. This service is also useful for those types of people who pay too much for basic medical needs. It is also beneficial for the people who are not able to go to the doctor’s clinic. In few words, we can say that it online medical services are demand of new age or age of technology.

Prescriptions are also available if you have internet access and a computer or other internet-connecting device, and are generally available throughout the day and early evening, Monday through Sunday. There is no need to wait in a queue to get the prescription. You can get it any time from day to night or from Sunday to Saturday. It is a fast and time flexible service as well as accessible from anywhere. It is the most convenience source for everyone.

Online medical help can be accessed with help of internet. Hellolyf is such an online platform that provides facility to consult doctor online. By browsing the website, you can get solution for almost all diseases. It is very easy to access online doctor consultation, as online services are usually available any time of the day or night. It is the best service for the people who are seeking basic primary healthcare services.

Online medical consultation service is the need of new age. By booking an appointment with a doctor, you can ask for online medical help. It is the useful service since you can book an appointment any time. Hello Lyf is an online platform for this service where you can book your appointment, in easy ways.

Longwood Medical Center

You have ever known the focus of medical teaching institutions and hospitals are the Longwood Medical and Academic Area. In addition to its affiliated teaching hospitals and other facilities is primarly the Harvard Medical School. But other establishments such as research centers and museums are also found here. Therefore, many students, academics and clients of the medical institutions are resident in the vicinity as might be expected of such an area.

 

Pride of place goes to the Harvard Medical School, one of the United States’ most famed medical faculties, as demonstrated by its current No. 1 ranking amongst research medical schools in the country. A graduate degree from this institution is considered to be one of the most prestigious qualifications one may hold.

 

The Beth Israel Deaconess Medical Center (BIDMC) functions as one of the Harvard Medical School’s premier teaching hospitals. It has the distinction of receiving one of the highest funding allocations for research among institutions of its kind, and conducts an immense variety of medical studies.

 

Another affiliate of Harvard Medical School is the Brigham and Women’s Hospital, which is noted as a premier center for cancer research with its status as a partner establishment in the Dana Farber/ Harvard Cancer Center, also resident in the Longwood area. Additionally it focuses on gynecology, kidney ailments and heart disease among other areas.

 

The Boston Latin School, one of the foremost educational establishments in the area holds the status of being one of the United States’ most acclaimed high schools. Inheriting a distinguished history, the school is noted for its curriculum which follows the Classical teaching methods including the requirement of Latin study for its students.

 

Other establishments of note in the Longwood Medical Area include the Children’s Hospital Boston, Joslin Diabetes Center and exceptional educational institutes such as the Harvard School of Dental Medicine, the Massachusetts College of Art and Design and many other premier colleges and schools.

 

The traveler in search of discount Boston hotels will find all that they seek in the BostonHotelseye.com online portal. This facility provides information about Boston hotels, and permits travelers to book their choice of the hotels in Boston online.

Medical Negligence and Duty of Care

Medical negligence can often be a grey area for lawyers and claimants to approach. By definition, medical negligence occurs when a doctor has been negligent in their care of the patient. The concept of negligence extends from doctors and other medical practitioners having a reasonable duty of care towards their clients. It is this concept of a duty of care that much of medical negligence law’s grey area comes from. In Australia, our understanding of duty of care and how far it extends is still being understood.

Here are four Australian cases where medical negligence lawyers sought to find the limits of the definition of duty of care:

1. PD v Harvey (2003) A patient claimed their doctor had been negligent in their service as a health professional as the doctor had not followed up on the patient after referring them to another doctor. The doctor was found guilty of medical negligence, confirming that duty of care goes beyond the consultation.

2. Brown v Thoo (2004) A patient claimed their doctor had been negligent by incorrectly administering a contraceptive device. Believing they were protected, the patient became pregnant. The doctor was guilty of medical negligence, confirming that duty of care can refer to preventing future medical issues to the best of their abilities.

3. Finch v Rogers (2004) A doctor did not request blood tests for their patient after a surgical procedure. Because of this oversight, the patient received unnecessary chemotherapy treatment. The doctor was found to be negligent, showing that duty of care extends to reasonable investigation of potential avenues of change in a patient’s health and wellbeing.

4. G and M v Armellin (2009) A patient had two separate embryos fertilised by their doctor without consent. The patient subsequently became pregnant. The doctor was found guilty, suggesting that duty of care extends to keeping a patient informed and seeking their consent when it comes to any medical procedures, within reasonable bounds.

If you are seeking medical negligence lawyers in Sydney, call BPC Lawyers on (02) 8355 4003, or enquire online at www.bpclaw.com.au.

Related Articles – medical negligence lawyers, medical negligence lawyers Sydney, compensation lawyers, compensation lawyers Sydney,

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Medical Tech Innovations That Promise Better Patient Care

When we talk about the fast moving society, we understand that we are advancing ever so fast into the future – and medical technological innovation is one such field. As medical technologies surge with unprecedented speeds and accuracy most of the procedures that were commonplace just decades ago seems so obsolete now. Therefore, as we look into the future, we see a new beginning of medical treatments that has made lives of doctors today so much easier.

The new medical technologies strike a great balance between reducing overall costs of health care and increasing safety and survival of patients. Listed below for your reference are five medical tech innovations that promise better patient care in the years to come.

Patch Biosensors allow needle-less diabetes care Diabetes in itself is a painful disease, ones who suffer with it know what we mean, but self-care of Diabetes adds tremendously to this pain. Diabetics require drawing their blood to keep a frequent tap on glucose levels, and others with high glucose levels require daily insulin shots. These not only cause pain because of all that pricking but also keep possibility of acquiring infections high.

Portable continuous glucose monitoring devices and insulin pumps have made the process of monitoring glucose levels a little automated, but even these have not been able eliminate the need of needle pricks and shots completely. Now Echo Therapeutics in Philadelphia is developing a diabetic patch which will eliminate the need for pricks completely.

Echo Therapeutics is developing a transdermal biosensor that can read blood chemistry from the skin, without the need of drawing blood. The patch-biosensor basically uses a handheld electric brush to scrap of the top layer of the skin to get the blood vital signals without a drop of blood. The sensor sends the data to a wirelessly connected monitor, where the users can keep track of their rising and dropping levels of glucose.

Robots have ventured into almost all forms of human existence; they can cook, dance, play and can even perform medical examinations like doctors. Telepresence robots are the best in the league and they are herald as robot avatars, and these robots in medical avatar can petrol the hospital rooms like routine rounds of the doctors and check patients in different rooms. RP-VITA Remote Presence Robot developed in collaboration with iRobot Corp. and In Touch Health is perhaps the first such autonomous Telepresence robot which has been approved by the FDA and has found its way into seven hospitals in various states of America and Mexico.

The medical professionals of these hospitals can control the RP-Vita using iPads and can monitor each patient’s individual charts, vital signs and carry out other kinds of precise examination courtesy the robot’s built-in two-way cameras. The doctors can zoom into each patient that the robot visit and diagnose them for all kinds of problems without being physically present there.

Growing half heartRobot doctors
Thousands of children are born with a condition called hypoplastic left heart syndrome, which causes the child’s left ventricle – heart’s main pumping chamber to stop functioning, which can be fatal. Common treatment for this includes open heart surgery, wherein the blood pumping task is shifted to the right ventricle, which along with handling low pressure blood flow to the lungs also gets an added responsibility of pumping blood out to the other organs of the body. This excessive pressure isn’t a sure shot solution and ultimately leads to casualty.

Now in order to help the left ventricle grow, surgeons at Boston Children’s Hospital have devised a way to open the obstructed valves and repair the problems to direct the blood flow to the left ventricle instead of away from it to the right ventricle. Thriving on the body’s natural capacity to heal, the surgeons have been able to re-grow the heart in 12 children.

Veti-Gel – anti-bleeding gel
Medical technological innovations usually require high budgets and lots of time, but sometimes and small idea can make a revolutionary change. Such is the case with Veti-Gel, an anti-bleeding gel like substance created by Joe Landolina and Isaac Miller. The Veti-Gel when applied on bleeding area, instantly seals the wound and starts the clotting process in no time. The gel mimics the properties of extracellular matrix, which naturally helps cells grow together – the anti-bleeding gel does exactly that, it allows the cells in the body to grow together faster.

The Veti-Gel has been tested in various clinical experiments and it has proven to be really effective. If the anti-bleeding gel actually makes it for real, it could be major life saver especially in the combat zones and sports fields.

Creating brain cells from pee
Almost all of us are familiar with the fact that embryonic stem cells were being used to create progenitor cells (which are used by the body as building blocks for brain cells). But, the fact is that these developed tumors after transplant. Now, with an objective to try creating progenitor cells in a new way, researchers at the Guangzhou Institute of Biomedicine and Health in China have used waste cell in urine to modify them with retroviruses to create progenitor cells. What has been amazing about using pee cells to create progenitor cells is that these have shown no signs of side effects. Biologists working on the innovative technology say that the newly formed neurons have not caused any kind of tumors in mice used for testing.

The main benefit of using cells for urine means that they will be freely available and that scientists will be able to create neurons from cells sourced from the same person, minimizing the risk of the cells not being excepted by the body.

AUTHOR BIO:
Mike Chapman is Health & Fitness Consultant Based in New York having 15+ years of experience working in clinics, gyms and also Yoga instructor dealing with health, pain and injuries often reviews weight loss and diet supplements for their safety, performance, side effects, efficacy and more. He provides professional assistance and advice on health issues and natural remedies currently associated with Leading Health Care organization.

Related Articles – Health, weight loss, Bystrictin, Stimtein,

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Order Cost Saving Medical Billing Softwares And Consultants Services

Medical practices and facilities use many software programs as well. These companies require software that is very detailed and specific. The reason is there are a lot of things that go into management.

A medical practice issues patient invoices and insurance bills. Patient scheduling and management of records is also involved. Another part of a practice is the management of lab tests and results.

The medical field has a lot of things to keep track of and maintain. For this reason, bespoke software is often sought out by practices. Various computer firms offer custom Medical Billing Softwares

Medical billing softwares have been developed for many practices. These practices most likely have many of the same software problems. This means many medical billing softwares have resolved issues.

Companies that create medical billing softwares work with clients. Each medical facility or office has different needs and expectations. These expectations are used to create the best software program.

The idea is to create effective functional medical billing softwares. Only effective software programs will help a medical facility. These help a medical facility manage invoices better get them paid.

Other helpful elements provided by computer companies are available. Medical billing softwares are used with medical billing consultants. Medical Billing Consultants provide an invaluable service to offices.

Medical practices often have difficulty getting invoices paid. The struggle is evident from patients and insurance carriers. Both of these groups sometimes put off paying medical invoices.

This is one of the many benefits of medical billing consultants. These consultants help in the process of collecting unpaid invoices. They have methods to effectively increase the number of paid bills.

Medical offices often have difficulty in collecting on these bills. The reason is medical offices have so many other things going on. Medical office personnel are not trained in how to collect on bills.

Medical billing consultants are professionally trained in this area. These consultants go through a lot of training to acquire the skills. There are other benefits to using medical billing consultants.

Medical billing consultants are also used to handle billing aspects. This frees up medical office personnel for other important things. Medical personnel can focus on providing quality care to patients.

Other services offered are for web ecommerce types of industries. Ecommerce websites require special websites and capabilities. This service is often provided by ASP Net outsource services.

ASP Net outsource is used on sites that sell a lot of products. These products must be managed into an online product catalog. Sites have product management capabilities through ASP net outsource.

ASP Net outsource services are written by various computer languages. The ASP Net Outsourceservice may use C# or VB Net languages. These languages are the most popular computer languages used.
ASP net outsource is best used by professionals in programming. The reason is that many new terminologies exists in the programming. Professionals who outsource ASP Net programming provide great sites.