Hello, I'm Pascal...
Pascal Werner is a quality management and regulatory affairs consultant with over seven years of experience in the EU with a strong focus on software as a medical device, especially AI and digital therapeutics.
He holds a master degree in biomedical engineering, has cofounded a startup previously, and has hands-on experience in software development.
He has a proven history of setting up or building out quality and information security management systems as well as crafting and reviewing technical documentations, including clinical evaluation, software file, usability engineering, risk management. Relevant norms include ISO 13485, IEC 62304, ISO 14971, and IEC 81001-5-1 amongst others. This work also includes performance of internal audits as well as management of internal audits.
He prefers working with clients to build out a good quality culture and strong processes where passing audits and reviews becomes second nature. However, he has also experience in remediating findings in technical documentation reviews as well as audit non-conformities.