Understanding International Standards for Medical Devices

Instructor: Mark Roberts
Product ID: 701622

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542


Read Frequently Asked Questions

This medical device training on International Standards will address various sources of external standards, how they are developed and the differences from region to region.

Why Should You Attend:
Is an ISO standard the same as the EN ISO version and what about the BS EN ISO version? Are all of them needed? Understanding where to obtain the correct and current versions of international standards and guidance documents is crucial to properly designing, testing and obtaining approval for medical devices. A medical device manufacturer who wishes to market their device must know how to determine the applicable standards and insure that the current version is available. Device approval, especially outside the US is driven by conformance to ISO, IEC and other standards. A device manufacturer must how to determine the applicable standards and guidance documents, keep them current and be on the watch for new ones.

This seminar will help you understand the alphabet soup of standards. The presentation addresses the various sources of external standards, third part standards, how they are developed and the differences from region to region. Examples and links to the various web sites is provided.

Areas Covered in the Seminar:

  • Sources of external standards / documents.
    • Standards Bodies – ISO, CEN, AAMI, etc
    • Regulations – FDA, MDD, CMDR
  • ISO, EN, BS EN, AAMI/ANSI – making sense of the standards alphabet soup.
  • Harmonized Standards – Source, meaning, updates.
  • Third Party sources of standards, ILI, BSI, etc.
  • Keeping up to date.
    • Requirements, resources, transition periods
  • Copyrights, filing, what standards do you need to have.
    • Discussion: Examples @ contractors, customers, etc.

Who Will Benefit:

The following individuals or disciplines will benefit from attending this Webinar:
  • QA Vice Presidents, Directors and Managers
  • Regulatory and Compliance Management
  • Document Control Specialists
  • Consultants
  • Quality System Auditors

Instructor Profile:
Mark Roberts, is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the Western US for TÜV SÜD Product Service. He is an accredited lead auditor and notified body auditor. He still performs audits and product/sterilization file reviews for notified bodies on a contract basis.

He has 30 years of experience in the medical device industry. Prior to joining TÜV he was with Becton Dickinson in their corporate offices as manager of sterility assurance. He also held various positions in RA/QA, sterility and engineering for Baxter Healthcare. He is a member of AAMI and ASQC Biomedical. Publications include portions of the ASQC Biomedical Quality Auditor Handbook. He has also been an expert witness on quality systems and sterility for the FDA.

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