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One-Stop Solution for all your Regulatory Requirements!

TIME CRITICAL SERVICES

Regulatory Strategy 

 

From idea to Commercialisation! 

Create a pathway to protect your innovation with complete compliance with regulatory requirements.

A well thought regulatory strategy enhances your production, business development and marketing plans.

 

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Representation Services

 

Regulatory First Responders for your medical device. 

We act as your EU AR / PRRC and represent your innovation to the European Commission! 

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EU AR/ PRRC 

Market Access 

 

Planning to enter the EU/USA?

Not sure about market entry requirements?

Worried about MDR/USFDA requirements?

We are here for you!

 

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YOUR Regulatory Risk Partners!

 

We have a list of ongoing and routine services through which we help our clients with complete regulatory compliance. 

Check our wide offerings for Medical Devices:

 

Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).

LATEST INSIGHTS

EU AI Act and Digital Health

EU AI Act and Digital Health

Would there a major impact on Digital Health?

8.5.2024

How to assign Master UDI-DIs to contact lenses: A new regulation update

How to assign Master UDI-DIs to contact lenses: A new regulation update

The European Commission on 20 October 2023 published an amendment which introduces a new concept of Master UDI-DI for contact lenses.

26.3.2024

eSTAR and Pre Market Approval

eSTAR and Pre Market Approval

On 6th December 2023, the USFDA announced the voluntary use of eSTAR - Electronic Submission Template.

29.2.2024