Alf’s foremost strength is creating quality management systems to an adequate compliance level, as well as maintenance and audits of the systems.
Alf has a 30+ years of broad experience in working with quality assurance and regulatory affairs in medical device business, mainly in small companies developing new products. He has significant knowledge how to create quality management systems for European, US and Canadian markets.
His experience covers the regulatory process for products of both high class (IIb and III) products, including combination products, and products of lower class and IVD’s. Alf’s experience includes risk analysis, biocompatibility evaluation and process validation.
“When do we start the quality and regulatory work in our small organization? How do we know what to do and where to start?” ”- The quality and regulatory process shall start as soon as you know what product you are to develop and what the intended use of the product is. If you have defined the intended use you can classify the product and then initiate the risk management. Out of these results a plan for quality system and technical documentation for the product shall be issued and developed.”