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QMS Consultancy Ltd

Introduction

QMS Consultancy is an independent consultancy firm with a proven track record of providing ISO 13485 compliant Quality Management Systems & product Technical Files for small to medium sized medical device companies.

It is our mission to build transparent, fully integrated and compliant systems that help support all aspects of business function, especially those necessary for CE Marking and launching new products.

We are pleased to offer the following services:

Quality Management System

A bespoke QMS, compliant to ISO 13485:2016, containing >50 procedures and associated forms can be fully operational within one week.

By working with the client and understanding their needs, we can quickly create, install and train a QMS that works in harmony with their business and fulfils all the requirements of ISO 13485:2016.

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CE Technical File Development

For companies developing new medical devices (MD, IVD's & Software), gaining Regulatory Approval can be a slow and confusing process. That is why we have developed the Technical File Template (TFT). The TFT can save you hundreds of hours of administrative work and will help you structure your entire Technical File. By using our TFT you can ensure you meet all the requirements necessary for Regulatory Approval. 

A TFT, containing more than 70 completed documents that are numbered, structured and bespoke to your company and the new product can be provided within one week! 

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Head of Quality and 'Management Representative'

QMS Consultancy offer an outsourcing service, that provides the reassurance of a full-time Quality Manager at a fraction of the cost. 
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Training, Coaching, Mentoring

  • Understanding ISO 13485:2016
  • Understanding the CE Marking process for Medical Devices
  • Understanding the CE Marking process for In Vitro Medical Devices

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Gap Analysis & Due Diligence

  • ISO 13485:2016
  • CE Marking for Medical Devices (MDR (EU) 2017/745)
  • CE Marking for In Vitro Medical Devices (IVDD 98/79/EC & IVDR (EU) 2017/746) 

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Supplier Controls

Supplier Controls are of particular importance for companies that outsource their manufacture to third parties. Control of Critical Subcontractors and Crucial Suppliers should form a major part of their Quality Management System.
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