However, there are also FDA requirements for reprocessing reusable medical devices. Most class II medical devices & even a few class I medical devices require 510(k) clearances before marketing them. When manufacturers submit 510(k)’s, they typically follow FDA guidance documents written for specific types of devices. Similar requirements can be found in European Union CE marking requirements. Hospitals & clinics have been steadily increasing their demands for detailed, written directions for processing reusable medical devices, regardless of the classification. This presentation will discuss these requirements.
Areas Covered in the seminar:
Who Will Benefit:
Manufacturers of reusable medical devices need to be aware of the requirements for reprocessing reusable medical devices, since both the FDA and the users will be asking for detailed reprocessing instructions. This Webinar will explain the regulatory requirements including cleaning and sterilization methods & validations. Some employees who wish to gain a better understanding include:
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 been 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 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.
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