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Over the last decade, Medical Regulations and compliance have had a significant impact on the medical device industry.
Developing an efficient regulatory strategy is a challenging task requiring in-depth knowledge and a thorough understanding of regulatory requirements
A regulatory strategy comprises 3 essential elements, Device Classification, Compliance Requirements and Compliance Ownership.
Regulations and Marketing are interdependent with regulation being the beacon light. Find out more.
Medical Devices are defined differently in different parts of the world. Read more to understand the right classification.
In the following series, Med-Di-Dia will help you create a strategy for entering the US and EU medical device markets.
Establishing the Target Market is a key step towards developing your regulatory strategy. Read about the USA and the EU medical device sales process.
FDA visits are common and can even be unannounced! Read this guide to stay up-to-date and avoid ‘tripping up’ when the FDA comes knocking on your door
UDI Compliance and its mandatory timelines.
If you have obtained approval or completed a Declaration of Conformity (DoC), here is a guide on affixing the CE Mark.
UDIs will play an important role in traceability and increasing the efficiency of post-market safety activities. Getting UDI for a Medical Device is a
With introduction of EU MDR what is SaMD and key updates on regulations of SaMD
A CE mark logo is an essential identification for medical devices of a certain class. Read about the process to obtain CE Mark.
From 26th May 2021 the new EU Medical Device Regulation (MDR) will be in full force. Tackle the changes coming in with Med-Di-Dia
MDR increases the complexity by introducing the need of a PRRC