Regulatory Affairs

Entrepreneurs in Health and High tech face many challenges when launching their product or service in the healthcare industry. One of the biggest challenges is complying with legislation, especially if you’re a company in the field of medical devices or pharmaceutical products. If you want to be competitive in the market, manufacturers need to be equipped with profound knowledge of all applicable rules and standards. And even more important: you must apply them all appropriately and traceably.

There are many rules and regulations you might need to comply with. Legislation for medical devices is particularly elaborate. Some examples: Medical Device Regulation (MDR), additional CE Directives, US Food and Drug Administration (FDA) and the Medical Device Single Audit Programs (MDSAP) for instance. In Europe Good Manufacturing Practice (GMP) compliance is required for all steps in the manufacture of prescription medicines.

It is crucial – even in the start-up phase – to equip yourself with sufficient knowledge about regulatory affairs. Our Briskr experts can help you with that. Contact us or register for one of our workshops to find out more!