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Date: Thursday 7 October

Time: 8:00 am CST

The regulatory landscape for medical devices is complex, which can make it difficult to navigate what is needed to gain approval in your chosen markets. With patient safety the aim, independent certification is an effective way to reduce business risks, to show you’re committed to the safety and quality of your products and to demonstrate that you meet the regulations.

During this live webinar, our technical experts will share their insight into two of the key medical device quality standards – ISO 13485 and the Medical Device Single Audit Program (MDSAP). Join our speakers who will share their insight on these standards, the audit process and ultimately how certification can give you and your stakeholders greater confidence in your products’ quality and compliance.

What will be covered?

  • ISO 13485 overview and audit process
  • Common areas of audit findings – pitfalls to avoid
  • MDSAP overview and its relationship to other standards
  • Q&A

Speakers:

  • ​​​​​John Howlett, Quality Manager - Medical, LR
  • Cheryl O'Rourke, Quality Assurance Manager - Medical Systems, LR

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