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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Services

We have expertise and offer support in many areas, including the following:

  • Development and implementation of Quality Management Systems (QMS)
  • QMS updates
  • Supplier assessments
  • Internal audits
  • Audit preparation and support, e.g.:
    Notified Body audits (CE certification or ISO 13485)
    US FDA Inspections
  • Medical Device Single Audit Program (MDSAP)
  • Audit nonconformance resolution / CAPA
  • Complaint and nonconforming product assistance

Development and implementation of Quality Management Systems (QMS)

Through gaining a thorough understanding the operations of a business, we can provide bespoke quality management system procedures to ensure the smooth running of the company and compliance with relevant QMS requirements.


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