The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing reusable medical devices.
Much attention has been paid to the regulatory requirements of reprocessing SINGLE use devices. However, there is increasing attention being directed towards reprocessing REUSABLE medical devices and regulatory requirements. The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing reusable medical devices.
Areas Covered in the seminar:
- Reasoning behind labeling requirements for reprocessing reusable medical devices.
- Regulations pertaining to reprocessing reusable medical devices.
- Differences in intended use & design that relates to reusable sterile devices.
- Specific cleaning & sterilization.
Who will benefit:
Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate labeling & reprocessing of reusable medical devoices as well as single use devices. Some employees who wish to gain a better understanding include:
- Quality & Regulatory Professionals
- Manufacturing & Design Engineers
- Marketing Product Managers
- Corporate & Operations Executives
Instructor Profile:
John Chapman, BS, MBA, RAC has over 30 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. 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 seminars on various regulatory subjects.
