Online Safety Community

Post market surveillance needs to be robust to avoid penal regulatory action

Post market surveillance (PMS) is a very important activity for manufacturers of medical devices. It needs utmost care in handling, because the FDA considers post market surveillance as one of its primary means for protecting public health.

Post market surveillance is, in simple terms, the monitoring of the performance and quality of a medical device after it has been released into the market. Although this is a very long phase which lasts till as long as the patient uses the product or it gets recalled; post market surveillance is necessary because a problem can arise at just about any stage of the product’s life.

Post market surveillance is built on many well-established principles of safety

Being a well-established discipline, post market surveillance is built on many well-established principles of safety. Some of the foundations on which the principles of post market surveillance are built are:

o  Unique device identifiers (UDI)

o  Electronic health records 

o  Medical device reporting

o  Device registries, and

o  Advance methods for evidence generation and data analysis

Despite the application of such concepts as mentioned above; post market surveillance is a discipline that is still evolving. So, given the primacy of its role in being a tool for protection of public health; those in charge of post market surveillance in medical device manufacturing companies need to be aware of what it takes to develop the capabilities for putting a foolproof post market surveillance system in place.

A learning session on how to get PMS right

The ways of doing this will be the content of a meaningful webinar that is being organized by Compliance4All, a leading provider of profession trainings for all areas of regulatory compliance.

Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, and who brings an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities, will be the speaker at this webinar.

To derive the benefit of Susanne’s rich experience with medical devices and to understand how to develop a program for solid post market surveillance, just visit http://www.compliance4all.com/control/w_product/~product_id=501156L...

Susanne will give an understanding to participants of the importance of ensuring product safety and its attendant patient safety at this session. She will analyze the fundamentals of this discipline and show how a medical device company can develop one of its own and develop the capabilities for a sound post market surveillance program.

This webinar will help participants build a PMS that will help arm them with the means of acquiring important information about the medical device, which will help reduce the adverse events.

Susanne will cover the following areas relating to PMS at this webinar:

o  Overview and Definitions

o  FDA Expectations, Regulations

o  Lessons Learned and Enforcement Case Studies

o  Medical Device Reporting

o  Investigating a complaint or MDR

o  FAERS–FDA Adverse Event Reporting System

o  Common Mistakes and how to avoid them

o  Preparing for an FDA or NB Inspection

o  Best Practices.

Views: 21

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Silvia Watson posted a blog post

How Can Crossfit Training Keep You Healthy and Fit?

CrossFit is the best way to keep your body active, your mind intrigued and your system alive. This is a high-intensity workout routine that involves strength building, muscle building and weight training activities along with intense aerobic workouts. People who indulge in CrossFitting at least once in a week are faster, nimbler and retain top shape throughout the workout time span.…See More
4 hours ago
John Robinson posted a blog post

Regulations in the US and EU Dealing with Combination Products

Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the nature and meaning of all the regulations. Such businesses…See More
Friday
Adam Fleaming posted blog posts
Friday
Alex posted a blog post

3 essential electrical safety tips for new students

Living away from home for the first time is an exciting, invigorating, and pretty daunting experience. While your first days at uni will be the time of your life, living away from your parents also comes with a new set of challenges.Aside from cooking and cleaning, one thing we take for granted is our parents’ knowledge of how to keep us safe. Electrical safety, in particular, is something not many first-time students know a lot about, but electrical accidents are…See More
Friday

Forum

Occupational Health and Safety 5 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tara safe on Thursday.

QlikView for its Safety Strategic Business Intelligence Solution Worldwide

QlikTech (NASDAQ:QLIK), a leading…Continue

Tags: Qlikview, safety

Started by nicolewells on Wednesday.

What's your favorite motivational/safety quote? 102 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by David Collins on Tuesday.

Business Intelligence with Big Data happens at Unipê

the college center of João Pessoa will preserve the 1st assembly at big records, geared toward professionals inside the regions of administration, economics, public control and facts technologies.…Continue

Tags: qliksensetraining, qliksenseonline, qliksense

Started by Soujanya Naganuri Nov 1.

Road Safety Solutions 13 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Barry Oct 26.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service