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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

Different types of ISO 13485 Audits

Different types of ISO 13485 Audits

Audits are a key component of ISO 13485:2016

30.11.2022

EURLs IVDR

EURLs IVDR

What are EU Reference Laboratories under IVDR? EURLs

9.11.2022

Protect Your ISO 13485:2016 Quality Management System – Mistakes to Avoid

Protect Your ISO 13485:2016 Quality Management System – Mistakes to Avoid

ISO 13485:2016 – your partial gateway towards market entry around the World!

24.10.2022