Medical Device Regulatory & Quality Consultants

Providing regulatory and quality solutions to the medical device industry.

Regulatory excellence in global market requirements, covering both established and novel technologies.


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Regulatory Affairs

We offer a full range of regulatory services from the initial regulatory strategy right through to approval and the post market phase. Our insight into the regulatory requirements will pave the way for a smoother route to market.


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Quality Assurance

Whether you are looking for assistance with internal audits and CAPAs or to delegate the running of your entire quality management system, we can provide the most appropriate solution to help.


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Design & Development

From retrospective design documentation for legacy devices to planning the development strategy for your new product, our knowledge of the regulatory requirements for medical device product development will ensure the most efficient use of time and resources.


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DEVICE

We are a small and dynamic medical device consultancy, meaning we can offer a more tailored and dedicated approach.

REGULATORY

Our medical device regulatory consultants have a wealth of experience in a wide range of device technologies.

DESIGN

The medical device design consultancy services that we provide are based on expert technical knowledge.

IVD

We have a wealth of IVD consultancy experience in the development and regulatory conformity of IVDs.


Services Overview

We provide a full range of regulatory, quality and design documentation services for a wide variety of medical technologies including:

  • Active medical devices
  • In vitro diagnostic (IVD) medical devices
  • Ophthalmic devices
  • Orthopaedic and dental devices
  • Software as a medical device
  • Surgical instruments
  • Vascular devices
  • Woundcare
  • Sterile medical devices
  • Devices with a measuring function
  • Reusable surgical instruments
  • Procedure packs
  • Devices containing:
    Medicinal products (combination products)
    Animal-derived materials
    Nanomaterials
Questions? Request information from our specialists

 
medical device consultancy
Providing regulatory and quality solutions to the medical device industry

Our Expertise

 

Regulatory Affairs

We offer a full range of regulatory services from the initial regulatory strategy right through to approval and the post market phase. Our insight into the regulatory requirements will pave the way for a smoother route to market.
Read more »

 

Quality Assurance

Whether you are looking for assistance with internal audits and CAPAs or to delegate the running of your entire quality management system, we can provide the most appropriate solution to help.
Read more »

 

Design & Development

From retrospective design documentation for legacy devices to planning the development strategy for your new product, our knowledge of the regulatory requirements for medical device product development will ensure the most efficient use of time and resources.
Read more »