harmonised and consensus standards
harmonised standards and consensus standards Developing a medical device will bring you and your team to the terms of harmonised and consensus standards. Read here… Read More »harmonised and consensus standards
harmonised standards and consensus standards Developing a medical device will bring you and your team to the terms of harmonised and consensus standards. Read here… Read More »harmonised and consensus standards
What you need to know when manufacturing custom-made medical devices Medical devices, and specifically implants, tend to become more and more patient-specific. Read here what… Read More »custom-made vs. off-the-shelf
How to best set claims for a medical device Claims for a regulated product are the promise to the user for its performance, safety, and… Read More »How to best set claims for a medical device
why choosing a consultant over a regular employee It is like a constant battle of thoughts. Should a company rather hire a consultant or aim… Read More »Why choosing a consultant over a regular employee
All you need to know about Common Specifications The new regulations for medical devices (MDR 2017/745) and in-vitro diagnostics (IVDR 2017/746) state common specifications. Even… Read More »What you need to know about Common Specifications
DHF, DMR, MDF, DHR – what do these terms stand for? When developing medical devices, you will come across specific terms especially when aiming for… Read More »DHF, DMR, MDF, DHR – what do these terms stand for?