John Chapman
Medical Device Consultant
John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union’s medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence on 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 2004Fundamentals 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.

John 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 on-line seminars on various regulatory subjects.
Upcoming Webinar
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Recorded Webinar
CE Mark - Required to Sell in the European Market
Medical devices sold into the European Union (EU) must comply with the applicable medical device directives, EU laws similar to FDA's regulations. Medical devices declared compliant must bear a CE mark in order to be admitted into the 27 member countries comprising the EU. The market population of these 27 countries is 450 million people, exceeding the 420 million people served by NAFTA (USA, Canada & Mexico), so many companies have an interest in penetrating this market. This presentation will provide an explanation in layman's terms of the various routes to CE marking of medical devices, with a focus on the Medical Device Directive, MDD 93/42/EEC.
Recorded Session Get life time access for one participant with download option!

Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements
The purpose of this webinar is to explain in detail the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.
Recorded Session Get life time access for one participant with download option!

Failure Modes and Effects Analysis - An effective Risk Management Tool
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".
Recorded Session Get life time access for one participant with download option!

Failure Modes and Effects Analysis - An effective Risk Management Tool
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 14971:2000Medical 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 referred to in ISO 13485:2003.
Recorded Session Get life time access for one participant with download option!

CE Mark - Required to Sell in the European Market
Medical devices sold into the European Union (EU) must comply with the applicable medical device directives, EU laws similar to FDA's regulations. Medical devices declared compliant must bear a CE mark in order to be admitted into the 29 member countries comprising the EU. The market population of these 29 countries is 450 million people, exceeding the 420 million people served by NAFTA (USA, Canada & Mexico), so many companies have an interest in penetrating this market. This presentation will provide an explanation in layman's terms of the various routes to CE marking of medical devices, with a focus on the Medical Device Directive, MDD 93/42/EEC.
Recorded Session Get life time access for one participant with download option!

Design Control for Professionals
Since 1984 the FDA has identified the lack of proper design controls as one of the major reasons for device recalls. This was the reason FDA formalized the legal requirement for design controls in the Medical Device Amendments of 1996. Device experts have estimated it cost 10 times more resources to correct a poor design after it has been in manufacture than to design it right to begin with. This is in addition to the bad publicity of recalls and other regulatory action. This webinar will emphasize key portions of good design control and poor design control along with some important tools learned by the author over the last 25 years.
Recorded Session Get life time access for one participant with download option!

ISO 13485-an Effective Quality Management System
ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.
Recorded Session Get life time access for one participant with download option!

Corrective and Preventive Action (CAPA)
Corrective and Preventive Action (CAPA) is a requirement under international standards such as ISO 13485:2003 and FDA under 21CFR 820.
Recorded Session Get life time access for one participant with download option!

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