FMEA and Risk Management for Medical Devices

Instructor: John Chapman
Product ID: 705700
  • Duration: 60 Min
This FMEA webinar will discuss how to use FMEA as a tool for risk assessment and how to make it an integral part of risk management. What are the harmonized standard of risk assessment of medical devices under MDD and how to use it in design control risk management.
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Why Should You Attend:

FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management. FMEA has been used as part of Risk Analysis under the obsolete standard EN 1441 - Risk Analysis for Medical Devices. The term “Risk Analysis” is no longer appropriate for medical device manufacturers and has been replaced by “Risk Management”. EN 1441 is now a withdrawn standard and ISO 14971:2007 Medical Devices -- Application of Risk Management to Medical Devices has been the harmonized standard for risk assessment of medical devices under the medical devices directives and has been emphasized in the new ISO 13485:2016.

This presentation will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

Areas Covered in the Webinar:

  • FMEA & FMECA
  • Risk Management vs. ISO 13485
  • Risk Management & ISO 14971
  • FDA’s Risk Management Requirements
  • Design Control Risk Management
  • Medical Device Directives & Risk Management

Who Will Benefit:

Employees who will benefit include:

  • Quality & Regulatory Professionals
  • Quality System Auditors
  • Manufacturing & Design Engineers
  • Marketing Product Managers
  • Operations Executives
Instructor Profile:
John Chapman

John Chapman
Manager & Regulatory Affairs, Cooper Surgical, Inc.

John Chapman, BS, MBA, RAC has over 35 years’ medical device regulatory experience and over 15 years’ experience with the European Union’s medical device directive, 93/42/EEC. Mr. Chapman has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence for over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification

(RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.

Mr. Chapman has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, auditing, root cause analysis, design control, bloodborne pathogens, hazardous waste handling, and FDA regulations. He has also presented live online seminars on various regulatory and quality system subjects.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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