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Client

Med-Di-Dia Ltd

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Med-Di-Dia Ltd is on a mission to be the leading Medical Technology Regulatory Affairs and Quality Compliance Consultancy in Europe.  To be the ‘go to’ consultancy.  They will cut through the maze of regulations and be a risk partner in the journey to the market never forgetting that, at journey’s end, patients will be the beneficiaries.

The Med-Di-Dia client portfolio ranges from University spin-outs, SMEs to Multinationals. Products are often cutting-edge with technology which is quite simply ‘mind blowing’.

Med-Di-Dia deal with a wide variety of projects and clients.  This exciting technology exposure, means exciting work!

The directors are warm and welcoming with an emphasis on community, family, support and nurturing. They provide a friendly and safe environment for consultant staff to grow and develop in areas of the business that interest them most.  They encourage individual contribution and through training, career opportunities, personal and professional development, they allow everyone the opportunity to learn, become experts and prosper.

Med-Di-Dia employees will have full and comprehensive support of their parent company GRS’s worldwide network of regulatory and quality compliance specialists.    

Time critical services:

Person Responsible

For micro and small companies, we will be your Person Responsible under the new EU Medical Device and In-Vitro Diagnostic Regulations.

Authorised Representative

For non-EU and UK companies, we can be your Authorised Representative within Europe.

Legal Representative for EU Clinical Trials

For UK organisations running EU-wide clinical trials, we will be happy to act as your Legal Representative to ensure continuity of your trials post-Brexit at a minimal cost.

Ongoing and routine services:

  • Help to define your product and develop your regulatory strategy.

  • Expertise to ensure a successful EU CE Mark registration.

  • Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems)

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

Testimonials

As a company GRS have been reliable, diligent with good administration. GRS have a good relationship with our small company, are respectful of deadlines and have a good understanding of changes that occur when working with small companies.  GRS have been very responsive to our needs including writing a presentation on a topic for us at short notice to support our business requirements.

Dr. Janetter Thomas - Atlantic Pharmaceuticals 

Given their extraordinary effort, and the experience I have had in dealing with GRS associates in general, I would recommend their services to any company looking to register their product in the global healthcare market. I have been particularly impressed by their attentiveness and their connections to regulatory agencies.

Dr. Katherine Middleton - Babylon