Recently, our QA/RA team gathered for an inspiring workshop where we not only deepened our expertise but also explored our creative side. We participated in an engaging activity led by Catarina Harling, Photographer and Teacher from the Fotografiska Museum. She taught us how to effectively use our iPhones for photography, with a particular focus on lighting techniques.
It was an educational and enjoyable experience that showed that our consultants are not only experts in their fields but also skilled photographers! With enthusiasm and curiosity, they quickly picked up techniques and captured each other’s best sides in stunning portraits. It was amazing to see how quickly they developed and how creativity flowed.
Meet some of our consultants
We’re thrilled to introduce some of our fantastic consultants! Since we now have such great photos that the consultants themselves took of each other, we thought we’d showcase the pictures and at the same time give you an insight into their expertise and what makes them unique in their fields.
PATRIK FÄLEMARK
SENIOR QA/RA CONSULTANT
Patrik will tackle your technical file, CE-marking, US applications and regulatory activities globally for you with confidence and expertise. He has more than 16 years of experience with medical devices within QA and RA, bringing senior-level expertise and a strong track record in the field. His background includes global responsibilities for all post-market surveillance activities, including complaint, Vigiliance reporting, Field Action and regulatory strategies, approvals and compliance activities.
CLAUDIA DANNEHL
SENIOR QA/RA CONSULTANT
Berlin-based Scientist and QA/RA/Clinical Generalist with a background in Physics and Biophysics and over 10 years of experience in the medical device industry. Combines collaboration, creativity, and pragmatism to develop smart solutions that help teams navigate European regulatory and clinical requirements with confidence. Claudia is passionate about innovation and patient safety, enjoys sharing knowledge – ideally over coffee, through community events organized, or as the host of a German-language MedTech podcast.
PÄR NEIDENSTRÖM
SENIOR QA/RA CONSULTANT
Pär brings extensive experience in quality assurance, auditing, product development, and regulatory compliance within medical technology supported by a long track record of hands-on work across a wide range of projects and organizations. He is recognized for his reliability, integrity, and pleasant demeanor. He excels in leading and organizing teams, understanding requirements, and being a supportive leader.
ANNA SZCZEPKOWSKA
QA/RA CONSULTANT
Anna is a skilled QA/RA consultant in the medical device industry, known for her responsibility, organization, and efficiency. She excels at managing large amounts of information and organizing it according to set guidelines. Anna is a reliable and hardworking individual known for her integrity and pleasant demeanor. She excels at listening and understanding others, making her a supportive and effective team member.
LARS MENTZER
SENIOR QA/RA CONSULTANT
Lars has worked in compliance in several companies in a worldwide environment since 1994, giving him a deep and well-rounded understanding of regulatory demands across different markets. Lars approaches challenges with a calm demeanor and a pragmatic mindset. He firmly believes that having a good grasp of the big picture enables better decision-making and effective navigation through complexities.
MALIN BORG
SENIOR QA/RA CONSULTANT
With a background in Engineering Physics and Computer Sciencem Malin brings over eight years of experience in the life science industry, specializing in QA/RA for medical devices across EU, UK, and US markets. She is a proactive and solutions-driven consultant known for her pragmatic and results-oriented approach. Malin possesses the ability to see the bigger picture while maintaining a keen eye for detail.
NADIA RAGNVALD CASPERSEN
SENIOR QA/RA CONSULTANT
Nadia is a trained lead auditor with several years of QA experience within the life sciences industry, including work in regulated environments and complex projects. Nadia is a reliable and hardworking individual known for her integrity and pleasant demeanor. Her commitment to her work and her ability to build trust with those around her highlight her strong character and dedication.
OLIVIA SUN
SENIOR QA/RA CONSULTANT
Olivia is a medical device professional with nearly 10 years’ experience of supporting organizations in CE-marking their medical devices, including establishing Quality Management Systems for ISO 13485 certification and compiling technical documentation for regulatory compliance. Experienced in working with a wide range of devices, including mechanical devices, substance-based devices, aesthetic devices and softwares. Personal strengths include thoroughness, an eye for details, reliability, adaptability, determination, and organizational skills.
OSCAR HE
SENIOR QA/RA CONSULTANT
Oscar is specialized in Management Systems according to MDR/IVDR, ISO 13485, and ISO 27001, as well as Regulatory Affairs. He is a certified auditor and expert member of TC 355 at the Swedish Institute for Standards. Passionate and driven professional with a keen eye for detail and a proactive and pragmatic approach to challenges.
Want to get in touch with our skilled team?
Whether you’re looking for expert guidance in quality assurance or regulatory affairs our consultants are here to support you with knowledge, experience, and dedication. Don’t hesitate to reach out – we’d be happy to explore how we can help you move forward.