Transition to MDR (EU) 2017/745 Certification

The MDR(EU) 2017/745 on Medical Devices introduced several new features and added stricter requirements than in the previous directives, which is [...]

With the MDR Regulation, it is strongly discouraged to assume that nothing has changed. The MDR gave the Notified Bodies a [...]

The fact that the device is always the same may be a plus point for obtaining CE certification. Still, nevertheless, data [...]

The consultancy route, particularly if one relies on a structured company, is the best choice to speed up the process of [...]

The MDR compliance process does not allow for haste and requires the right timing to resolve and fill all deficiencies. Compared [...]

Having an ISO 13485:2016-certified quality management system is an excellent starting point; being a harmonised standard, it confers a presumption of [...]

The requirements for obtaining the CE certificate are very stringent because devices placed on the EU market must be safe and [...]