Medical device manufactures 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 US FDA regulations.
With this context, IBM in association with Nohau, MicroGenesis and QAdvis is pleased to host a webinar titled Accelerating Innovation and Streamlining Compliance for Medical Device Engineering.
The webinar will focus on 3 Strategic Themes: Reduce Time to Innovation, Improve Quality and Reduce Cost of Compliance
Reduce Time to Innovation:
- Adopt agility at scale that meets the needs of each part of your development team.
- Reduce time to market with strategic reuse by creating and managing product variants across multiple product lines
- 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 Compliance:
- 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
Keynote: Tommi Varjonen – AI Applications Nordic Leader (IBM)
Moderator: Mr. Dhananjaya K, Vice President – Service Delivery ( MicroGenesis)
Industry Expert Speech: Robert Ginsberg – Co-Founder and COB (QAdvis)
ELM Presentation: Michael Halder, Offering Manager – Engineering Lifecycle Management (IBM)
Demo: Nicky Chris John, Manager – Technical Services (MicroGenesis)
Closing Remarks: Joakim Nilsson – Key Account Manager (Nohau)
Submit the form to secure your place to this exclusive webinar!