Insight Blog

Setting the record straight…. what do some terms and phrases mean within the ISO13485 Standard

An opportunity came up to help provide clarity on some of the specifics within ISO13485 during a regional conference recently. These slides provide explanation to some of the terms and phrases within the Standard. Hope it helps the auditee and the auditor of any medical device company, or certification company, understand the ISO13485 Standard better.

Also included are some of the new definitions that would be included in the proposed revision, and they’ll be updated as information arrives. Feel free to post your questions and hope we can help you with them!

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MedTech Gateway – December 2024

Dear Valued Clients and Partners,

As we embrace December, the final chapter of a year marked by transformation, we at Access-2-Healthcare are delighted to connect with you. Hope everyone closes the year on a high.

We sincerely appreciate the trust and partnership you have shown us, not just in the past year but these 9 years. With our 10th year approaching, let’s continue to drive innovation, achieve success, and make meaningful progress in the field of medical devices as we close this year and look forward to the future.

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