- Reasoning behind labeling requirements
- Regulatory requirements
- Intended use and design
- Validating cleaning and sterilization
This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.
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.
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