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Notified Bodies in EU MDR 

Notified Bodies in EU MDR 

Easy to understand blog on Notified Bodies… Read More

22.7.2021

One month from the application of the EU MDR – Let’s Revisit and Reflect!

One month from the application of the EU MDR – Let’s Revisit and Reflect!

Over the last decade, Medical Regulations and compliance have had a significant impact on the medical device industry.

29.6.2021

Where to start with developing a Medical Device Regulatory Strategy?

Where to start with developing a Medical Device Regulatory Strategy?

Developing an efficient regulatory strategy is a challenging task requiring in-depth knowledge and a thorough understanding of regulatory requirements

26.6.2021

Aspects of Regulatory Strategy

Aspects of Regulatory Strategy

A regulatory strategy comprises 3 essential elements, Device Classification, Compliance Requirements and Compliance Ownership.

24.6.2021

Can the regulatory strategy define medical device marketing strategy?

Can the regulatory strategy define medical device marketing strategy?

Regulations and Marketing are interdependent with regulation being the beacon light. Find out more.

20.6.2021

Understanding the meaning of Medical Device and Medical Device Regulatory Strategy

Understanding the meaning of Medical Device and Medical Device Regulatory Strategy

Medical Devices are defined differently in different parts of the world. Read more to understand the right classification.

18.6.2021

Define your product and develop your regulatory strategy

Define your product and develop your regulatory strategy

In the following series, Med-Di-Dia will help you create a strategy for entering the US and EU medical device markets.

16.6.2021

Who Can Sell in the USA and the EU Medical Device Markets?

Who Can Sell in the USA and the 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.

14.6.2021

How to prepare your medical device company for an US FDA inspection

How to prepare your medical device company for an US FDA inspection

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

9.6.2021