REGULATORY AFFAIRS

Responsive, expert regulatory advice at all stages in the medical device lifecycle

An understanding of the applicable medical device regulations is of crucial importance to a successful medical device business, especially in the current environment leading up to implementation of the new Medical Devices Regulation (MDR).

At all stages of the product life cycle, from pre-clinical assessment and clinical trials through product approval, post market surveillance and vigilance, MedPass provides the expert regulatory advice you need to get your product on the market and keep it there. Our regulatory consultants are experts in their diverse areas of expertise and include both Notified Body and Competent Authority credentials.

Whether your need is:

  • To obtain approvals for a clinical investigation,
  • To obtain CE marking for Europe or registration for placing on the market,
  • To comply with Post Market Surveillance requirements
  • To carry out a Field Safety Corrective Action
  • To comply with Vigilance Reporting requirements MedPass has the regulatory expertise needed to guide you through the process.

Building on our strong working relationships with Government Authorities and Notified Bodies across Europe and our long-standing reputation as the foremost Medical Device CRO and Regulatory consultancy in Europe, we provide the in-depth, up to date, country by country knowledge that is crucial to successful EU regulatory compliance for our clients’ medical devices. We deal on a daily basis with regulatory issues across a broad spectrum from labelling review to design dossier preparation across all product classes from Class I devices to active implantables.

CLINICAL INVESTIGATIONS APPROVALS

Processes and timelines for obtaining approval to start a medical device clinical trial differ from country to country. Furthermore, additional local requirements often apply. This makes the regulatory approvals process very complex, especially for multi-center, multi-country clinical investigations.

MedPass’ regulatory affairs team has in depth, up to date knowledge on local requirements across Europe for both pre- and postmarket clinical trials. This enables us to help develop effective submission strategies. Our teams are highly organized and our processes designed to effectively track all the various timelines and requirements. Clients benefit from our unparalled approval and timelines track records.

REGULATORY CONSULTING

MedPass’ regulatory affairs team deals on a daily basis with diverse regulatory issues across the whole range of product classes, from ‘low risk’ devices to active implants. No other Medical Device CRO or Consultancy in Europe offers expert advice in such a broad range of expertise:

  • Device Classification
  • Risk Management
  • Biological Safety
  • CE Marking and the MDR
  • Human/animal tissue products
  • Communication with Competent Authorities and Notified Bodies
  • Vigilance and Safety Reporting
  • Field Safety Corrective Actions