Do you need assistance with the regulatory process to obtain CE Marking in Europe or FDA 510K Clearance in the US for your medical device?
Do you need assistance to set up and manage a clinical study?
For medical device clients we can offer an established and dedicated team with experience and competence in pre- and post-market regulatory requirements in Europe and the US. The LINK Medical Device team is knowledgeable in medical device regulations and standards. Moreover, we offer expertise within project management, quality assurance, health economy, statistics, medical writing, data management and pharmacovigilance/medical device vigilance, as well as conducting and reporting clinical studies for drugs and medical devices.
LINK Medical is a European full-service CRO with more than 100 experienced and dedicated employees providing project management and product development services for the pharmaceutical and medical device industry.
Headquartered in Oslo, with offices in Copenhagen, Stockholm and Berlin, make LINK Medical well positioned to follow your products from product initiation to product launch.
Our long experience managing services for local and international clients is highly valued, especially on projects requiring a partner with local knowledge, an extensive network and skilled resources.