Manufacturers of in vitro diagnostic (IVD) devices planning to place products on the EU market under Annex IX of the IVDR must undergo quality management system (QMS) audits by a Notified Body. These audits evaluate the manufacturer's QMS to confirm compliance with IVDR requirements, covering the entire product lifecycle – from design and development through to post-market surveillance.
With the IVDR transition period ending on May 26, 2025, all IVD manufacturers must have an IVDR-compliant QMS in place. Now is the time to apply to a Notified Body and ensure your systems are aligned with regulatory expectations.
This webinar will provide an overview of the QMS audit process under the IVDR and share practical guidance to help manufacturers prepare effectively.
Agenda
- Objectives, criteria and scope of a QMS Audit
- Certification cycle and audit types
- Differences and synergies between an ISO 13485 audit and an audit under IVDR 2017/746
- QMS audits outcomes
- Why is it important to apply for the IVDR now?
- Application process and timelines at SGS
- Q&A
Target Audience
This webinar is intended for in vitro diagnostic medical device manufacturers globally, including corporations, SMEs and start-ups. It is especially relevant for Persons Responsible for Regulatory Compliance (PRRCs), EU Authorized Representatives, and professionals working in regulatory affairs, quality, technical, R&D and validation functions, along with their respective teams.
Language: English
Cost: No Charge
