Design Requirements Testing Workflow

Streamlining medical device design for US FDA Compliance

Three key themes to set up your engineering for success

Engineering Medical device manufacturers must innovate to succeed. To grow, manufacturers must deliver innovative, safe, and fully compliant medical devices. This means adhering to increasingly rigorous regulatory standards like ISO 13485, IEC 82304-1, ISO 14971, IEC 60812, IEC 62304, ISO 60601, IEC 61508, 21 CFR 820.30, and 21 CFR 11 driven by both EU's MDR and the regulations. IBM 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 design control as a by-product by creating work products in a controlled environment

−Use AI to validate quality of requirements 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 compliance and audit requirements