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
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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
Risk management strategy for medical devices
Risk management as a strategy Risks are almost inseparable from any entrepreneurial activity and especially during product development. For this reason, risks also have a… Read More »Risk management strategy for medical devices
Standardizing the PMS
Standardizing the PMS You have a medical device on the market and are subject to Post Market Surveillance (PMS), right? Well, how do you conduct… Read More »Standardizing the PMS
One of our services is your quality assurance
One of our services is your quality assurance Quality assurance is a component of quality management, consisting of all technical and organizational measures for the… Read More »One of our services is your quality assurance
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