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Smooth transition from IVDD to IVDR with Med-Di-Dia!

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!

Med-Di-Dia will be your Regulatory Risk Partner!

 

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

Check our wide offerings for IVD:

  • EU Representation
  • CE Marking
  • USFDA Submissions
  • Define your product and develop your regulatory strategy.
  • Assessments against new EU IVD regulations (2017) to assist with the transition.
  • Design control (verification & validation).
  • Design file compilation.
  • General Safety and Performance Requirements (GSPRs) checklist.
  • Risk management analysis (ISO 14971:2019).
  • Patient information management (IFU, labelling and Cartons).
  • Device classification & predicate device searches (US).
  • Unique Device Identification (UDI).
  • Global Unique Device Identification Database (GUDID).
  • Sterilisation validation report.
  • Performance Evaluation Reports.
  • Investigator's brochure.
  • Patient consent.
  • Review of summary of pre-clinical data etc.
  • Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems).
  • Internal audits, vendor audits, quality and regulatory compliance audits.
  • Technical file compilation.
  • Submissions/registration management.
  • Follow-up meeting to discuss & resolve Q&A from submissions & registrations.
  • Adverse events monitoring & reviews including devices undergoing clinical investigation.
  • Review & management of product recalls.
  • Cybersecurity/GDPR.

 

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