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Streamlining medical device design for US FDA Compliance

Three key themes to set up your engineering for success

Engineering manufacturers must innovate to succeed. To grow, manufacturers must deliver innovative, , and fully compliant . This means adhering to increasingly rigorous regulatory standards like ISO 13485, IEC 82304-1, ISO 14971, IEC 60812, IEC 62304, ISO 60601, , 21 CFR 820.30, and 21 CFR 11 driven by both EU's MDR and the regulations. helps to:

Reduce time to innovation

−Adopt agility at scale that meets the needs of each part of your development team such as SAFe®

−Reduce time to market with strategic reuse by creating and managing product variants across multiple product lines Improve quality−Achieve transparency and traceability for control as a by-product by creating work products in a controlled environment

−Use AI to validate quality of reduce cost of −Understand status, responsibilities, audit trial and history for design control work products at every stage of the development−Automatically generate high-quality documents from multiple sources to support and audit requirements

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