Regulated industries, such as the medical device industry, demand by Regulation the implementation of a Quality Management System (QMS). There is no exemption for the… Read More »Who has to implement which processes under ISO 13485
Design Transfer is a key concept in transferring the device design from development to manufacturing. But what should a person in charge of the Design… Read More »Knowing the core of Design Transfer
The submission routes for Combination Products can be overwhelming. Read here the hack to the submission routes with the FDA for Drug-/Device-/Biologics Combination Products. the… Read More »FDA Combination Product submission routes
CE-mark, the European sign of conformity, is something that is adulterated sometimes. But how to identify a correct CE mark? Read the unique identification specifics… Read More »How to identify a correct CE-mark
Ever wondered what the differences between the consultation procedure and the Notified Body opinion is or are you confused on the terms? Then read on…… Read More »The difference between Consultation Procedure and Notified Body Opinion
The Performance Evaluation Consultation Procedure (PECP) is defined in the IVDR 2017/746 as a mandatory process for certain in-vitro diagnostics. Read here what to look… Read More »All you need to know about the PECP
The Unique Device Identifier, short UDI, has become the identification to track and trace the medical device and in-vitro diagnostic on the market. As the… Read More »How to assign the UDI correctly
Cleanroom, or no cleanroom is a question to be answered when planning to manufacture a medical device or in-vitro diagnostic. But do you know how… Read More »How to choose the correct cleanliness level for manufacturing
The Unique Device Identification (UDI) is demanded by the regulations MDR 2017/745 in article 27 and in the IVDR 2017/746 in article 24. The UDI… Read More »How to add the UDI-creation process into your QMS
The MDR 2017/745 does restrict the use of equivalence to existing devices, sometimes referred to as predicate devices. Read here what you need to know.… Read More »Equivalence under the MDR
