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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!

 

Contact Us Now!

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

Risk Management Analysis (ISO 14971:2019)

Risk Management Analysis (ISO 14971:2019)

Medical Device Manufacturers have a legal obligation to regularly maintain and perform risk management analyses.

15.7.2022

Patient information management (IFU, Labelling and Cartons)

Patient information management (IFU, Labelling and Cartons)

A ‘Label’ is the identity of the product.

15.7.2022

Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)

Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)

It allows the identification of specific devices on the market and facilitates their traceability.

15.7.2022