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Panel on IVDR Compliance - Strategies for Ensuring Your Product Meets Quality & Compliance Requirements, Isabella Schmitt:
The number of products that fall under IVDR regulations is large and depending on where your products are sold, you will have to be compliant in those countries. In vitro diagnostics manufacturers must apply for EU products by May, 2022, to get products CE-marked under the new Regulation. Join our panel to talk about strategies for keeping your quality and compliance program up to date, and how to scale up to meet these needs. Topics include:
- Challenges and opportunities for engineers during product development to keep IVDR compliance and quality systems in mind
- Understanding the complexities of QMS and PMS for rapid diagnostic products
- Case examples and industry experiences relevant to engineers, such as legacy products
