Senior Consultant QA/RA
Medical Device Project B.V.
I am Vincent van der Meer and work at Medical Device Project B.V. (a.k.a. MDProject) in The Netherlands. As a consultant in Quality Assurance & Regulatory Affairs, I support manufacturers in their design & development activities, manufacturing processes and verification & validation projects, with regulatory requirements (such as EU MDR), international standards (such as ISO 13485) and industry best practices in mind. On behalf of MDProject, I teach a course at NEN (Royal Netherlands Standardization Institute) about the EU MDR. I'm also the trainer for MDProject's in-house courses "Software Development according to MDR and IEC 62304" and "UDI & Eudamed". Naturally, I’m an advocate of IT solutions to effectively control quality processes. Reduce paper waste, save your time, have more fun!
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Application of Article 61(10), Non-Clinical Data, for SaMD and AI
Wednesday, May 8, 2024
10:25 – 11:25 CEST