Design control has been a legal requirement for over 30 years, yet many firms fail to take full advantage of a controlled method for introducing new products or changing existing products costing millions of dollars and injuring both patients and health care professionals.
Why should you attend:
Fear, uncertainty and doubt (FUD) liner for the marketing purpose
A sound design control system will help avoid:
·Recalls resulting from improper design
·Problems from improper design control resulting in loss of CE marking
·Class action lawsuits for shipping poorly designed devices
·Expensive post market repairs & warranty costs
Description of the topic:
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.
Areas Covered in the Session:
Who will benefit:
Related Technical Document:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
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. 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. RAB Accredited Lead Auditor Course Certificate1996. 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. 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 and quality system subjects.