Webinar ISO 14971 Application of Risk Management to Medical Device : Follow the Process – Avoid the Problems

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Listen From Mike Colvin Ph.D have over 100 domestic and International patents issued."

This Webinar provides an introduction to risk/benefit analysis concepts for medical devices and IVDs

Description

The medical device/equipment field is one of the most heavily regulated industries, for obvious reasons.  Medical equipment are an important tool in efforts to improve patient care and treatment outcomes. However, today’s advanced medical devices usually consist of unique combinations of mechanical, electrical and electronic components and technologies that are frequently controlled by software or programmable controllers. As a result, international regulations and standards applicable to medical devices are being continuously revised and updated to reflect potential safety issues that can result from increasingly complex device designs.
While all medical device and in vitro diagnostic (IVD) manufacturers that claim conformity to ISO 14971:2007 should be familiar with the risk management documentation requirements established in this standard, small and medium-sized manufacturers frequently encounter challenges in preparing their risk management files, especially those wishing to market CE marked devices in accordance with the requirements of EN ISO 14971:2012.
This Webinar provides an introduction to risk/benefit analysis concepts for medical devices and IVDs, including a general overview of the differences between these two versions of ISO 14971 and the European Directives in relation to risk/benefit analysis, and descriptions and summaries of
the tools and resources available for use in these types of analyses.

Why should you attend : 

This Webinar is geared toward those who require a working knowledge/understanding  of ISO 14971

Areas Covered

The areas that will be discussed in the webinar will include the following topics:
•     Introduction and History of ISO 14971
•     Design Controls & Risk Management
•     Risk Management Process Overview
•     Role of Management in Risk Management
•     Risk Management Plan
•     Risk Management File
•     Risk Assessment = Risk Analysis + Risk Evaluation
•     Risk Controls
•     Overall Residual Risk Acceptability
•     Risk Management Report
•     Production & Post-Production Information

Who will Benefit

•      Medical Equipment industry Managers, Supervisors, Employees,
•      Electronic  Industry Managers, Supervisors,  Employees,
•      Quality Assurance Personnel,
•      Strategic Planners,
•      Technical Consultants

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Mike Colvin Ph.D.

Mike has over 30 years experience developing medical devices and systems. Over his career he has been in charge of safety & efficacy testing and Regulatory & Clinical strategies. He has also served as a technical advisor/consultant in the medical device industry for over 25 years, giving him exposure to both large medical device companies and start ups.

Mike has taught college for over 25 years and has contributed/participated on many domestic and international technical committees. He holds a Ph.D. in Physical Chemistry from the University of Southern California/California Institute of Technology.

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