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?
Medicinal Cannabis and the GACP/GMP jungle Medicinal Cannabis can support various treatments in reducing side effects and symptoms, such as nausea and pain. Medicinal Cannabis,… Read More »Medicinal Cannabis and the GACP/GMP jungle
Plants in pharma – what you need to know In highly regulated industries, quality management systems (QMS) and documentation are key to compliance and quality… Read More »Plants in Pharma – What you need to know