Labquality strengthens its regulatory affairs service capabilities and expands to Sweden

Labquality, supported by Mérieux Equity Partners, acquires QAdvis AB.

Labquality Corporation acquires Swedish QAdvis AB, which specializes in quality management and regulatory affairs services for medical device and in vitro diagnostic device manufacturers. They have a strong position in the Swedish quality and regulatory affairs services market. QAdvis also has broad experience and know-how in medical device software, from risk management and validation to quality assurance. The acquisition aligns with Labquality’s international growth strategy and enables Labquality to enter and grow its business in Sweden.

The acquisition enables Labquality to expand market coverage in the Nordics further. “QAdvis fits perfectly into our Labquality family, complementing our regulatory affairs and quality management business. In fact, the acquisition will significantly grow our regulatory affairs services offering. Particularly, their experience and competence in medical device software will further strengthen our position in the digital health market. Additionally, QAdvis is well connected to national and EU regulatory bodies and committees”, says CEO Juha-Pekka Nuutinen from Labquality.

“With Labquality, we form an excellent platform for our teams to further grow and support the medical device industry. We are convinced that this platform will be very valuable for our combined client bases. Labquality has an established and highly valued regulatory affairs expertise and a clear strategy to take its business to the next level. Becoming a part of Labquality enables us to combine better and leverage our quality and regulatory affairs services to the Nordic and international markets. We look forward to working within the Labquality team”, concludes Robert Ginsberg, the CEO of QAdvis.

The acquisition strengthens Labquality’s position as an expert services provider for the health technology industry.

The acquisition does not impact the current customer relationships, partnerships, or personnel of QAdvis or Labquality.

For queries, please contact: 

Juha-Pekka Nuutinen
CEO | Labquality
+358 40 828 3210 | jp.nuutinen@labquality.com

Robert Ginsberg
CEO | QAdvis
+46 760 199 469 | robert.ginsberg@qadvis.com

Labquality

We create quality excellence in healthcare on every continent. That’s our vision.

We are quality makers – a team of experienced experts in healthcare and health-tech quality. Our quality services for the healthcare, pharmaceutical and medical technology industries cover external quality assessments, regulatory consulting, clinical investigations and trials, audits and certifications, and training. Our expertise and knowledge benefit medical device and in vitro diagnostic manufacturers, pharmaceutical companies, healthcare units, and clinical laboratories.

Currently, we serve customers in over 60 countries. Our team comprises 150 skilled professionals, and our offices are in Finland, Poland, and Germany.

For more information, please visit www.labquality.com.

Mérieux Equity Partners

Founded in 2009, Mérieux Equity Partners (“MxEP”) is a leading European healthcare-specialized investment firm, with two dedicated platforms, Venture Capital and Buyout, supporting companies ranging from start-ups to established leaders. Benefiting from a longstanding expertise and a large network, MxEP invests in companies with ambitious growth projects and products or services transformative for Health. MxEP is AMF-accredited and currently manages c.€1.5bn of AuM. Labquality has been supported by Mérieux Equity Partners since November 2023.

For more information, please visit www.merieux-partners.com. 

QAdvis

We simplify regulatory complexity to accelerate successful market availability of safe and effective medical devices for the improvement of health and human lives across the globe.

We have long experience and international backgrounds from the medical device industry, academia, Notified Body and Competent Authority. We participate in international medical device standard committees and are stakeholder representatives in Eu Commission MDCG working groups.

Our services include quality management, regulatory affairs, clinical evidence, risk management, software, interim management, strategic advice, due diligence, auditing, training, etc. QAdvis mainly targets the Nordics but have clients all over the world. QAdvis provides Authorized Representation services in the EU and UK through separate QAdvis companies in Sweden and the UK.  

For more information, please visit www.qadvis.com.