We understand you. The best thing to do is to bury your head in the sand and push away the increasingly restrictive and complex legal requirements. Market access for medical devices is becoming increasingly difficult. And not without good reason, of course. And strictly speaking, there are also opportunities here to positively set oneself apart from the competition and gain market advantages for oneself. And there is help.
Whether you call it a contract research organization, a contract research organization or a clinical research organization, their job is to work with you to find the appropriate and correct path to clinical evaluation, to plan and conduct clinical evaluations and clinical trials.
Peter Hartung (Head of Consulting, QM and RA at seleon GmbH) says: “The challenge is not so much the practical conduct of clinical trials, which is carried out by investigators, but rather the planning, organization, support and monitoring. Medium-sized companies in particular often lack the resources and know-how here.”
Proof of clinical evaluation is now mandatory for the approval of medical devices. seleon therefore says “NO RISK APPROACH” – let us tackle the challenge together and benefit from experience, know-how and resources.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
