Wessel K.

Managed software development teams working under IEC 62304 for FDA and EU submissions (CE,MDR,MDD). Participated in audits for ISO 13485. Worked with engineering teams to produce documentation including: Architecture Document, SOUP/OTSS documentation, Software Detailed Specification, Software Requirements Specification. Rolled out eQMS solutions and set up software risk management according to ISO 14971 using ALM software. ALM setups to allow auto-generated Traceability Matrix document. Led the software development for medical devices in several prominent startups as CTO, including ISO 13485 certification and IEC 62304 compliance and CE marking under MDD and MDR. Worked as CEO, CTO, Project Manager and developer in Amsterdam, San Francisco, Paris and Brussels. Expert on managing software development teams and processes, roadmap management.