Declaration of Conformity
How to establish a compliant declaration of conformity The EC Declaration of Conformity (DoC) is the formal act of a manufacturer to declare that the… Read More »Declaration of Conformity
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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
custom-made vs. off-the-shelf
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
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
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
What you need to know about Common Specifications
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?
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 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
Medical grade plastics
Medical Grade Plastics – what it really is Medical Grade Plastics (MGP) or polymers, a term lately been found to wander around among medical device… Read More »Medical grade plastics
Plants in Pharma – What you need to know
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
