Jude
Forum Replies Created
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Had a few minutes and thought I would add to the discussion.
Using consistent and accurate terminology is critical to assure a common understanding and alignment with regulatory authorities and within your organization. I have worked with clients that tend to create there own terminology and I can assure you it not only confuses regulatory authorities but creates confusion within ones quality system. For your specific question I would believe that both terms will move forward interchangeably until such time as the FDA completes the transition and training of the investigators. My suggestion is to align with 13485 / 9001 terminology right away. This allows the FDA and the remainder of regulatory authorities outside of the FDA to clearly understand your Quality System documentation.
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Hi Holly, I would love to share the definition comparison. I am unable to upload to this site. Any help would be appreciated. TY
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Hi Holly, I think that would be a valuable tool to help facilitate common understanding of similar terms. I do think the transition to a common 13485 terminology may take years as these terms are well ingrained into corporate culture. Would you like me to put something together ?
