Mikael has 20+ years of experience of the entire chain for product development (from requirements to verification/validation of the product), process improvements, quality assurance and regulatory approvals. He has developed strategies for global regulatory submissions. He is often engaged to conduct analyses, planning and implementation of product development and process improvement projects.
Mikael holds an MSc in Electrical Engineering from the Royal Institute of Technology in Stockholm and is Certified Lead Auditor (ISO 13485). He is a member of the Swedish national standardization committee for IEC 60601-1 and related standards.
“Our company cannot manage all the requirements from regulatory bodies. It is only about producing paper, nothing that benefits our customers.” ”My mantra is to work risk-based. Always start with the risk analysis. Concentrate your efforts where there is the highest potential to cause harm. In the end you will notice that focused efforts have increased safety of your product and streamlined your development.”