Meet our expert Anna-Karin Alm
Anna-Karin joined SDS in 2019 and is head of the rapidly expanding Medical Device team. Anna-Karin has 20 years’ experience from numerous well-known medical device companies and has worked with research, development and quality management systems. Anna-Karin has led and implemented extensive changes of Design Control and Quality Management Systems and is passionate about understanding a client’s business strategies and vision to provide relevant regulatory strategies and efficient product development and quality activities.
What is the main challenge with the upcoming MDR deadline?
“It is understanding how to ensure that the increased regulatory workload will generate value for the business, not only through released products, but also through an increased efficiency of the organization and its quality processes.”
What is your most common advice to clients?
“Ensure that there is a clear business decision for your product’s intended use and market. Establishing this will ease the planning of the right regulatory strategy and efficient product development and quality, thus avoiding pitfalls along the way.”
Anna-Karin supports clients in medical device development with both EU and US compliance, both at strategic and operational levels.