Articles Medical Devices Regulatory Affairs
5 questions on Regulatory Affairs in the Medical Device Industry
As an integral part of the healthcare world, the medical device industry must comply with a dedicated regulatory framework to protect the patient and ensure health benefits. The different tasks of the AR department imply a central position in the internal and external interactions of the company. The manufacturing of a DM is organized according to a "Supply Chain". It includes the different departments of the company, whether technical, support or commercial, but also numerous suppliers and subcontractors. Since regulatory requirements apply to the entire manufacturing process, the RAs interact with all the players involved, particularly through regulatory audits.