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An independent consultancy firm with a proven track record of providing ISO 13485 compliant Quality Management Systems & product Technical Files for start-up & early-stage medical device companies.

We are pleased to offer the following services:

QMS - 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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TFT - Technical File Template

For companies developing new medical devices (including 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 >70 documents that are numbered, structured, semi-complete and bespoke to your company, can be provided within one week! 

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Training, Coaching, Mentoring

To ensure better understanding of medical device regulations, Richard offers free consultancy, coaching and mentoring for individuals and start-up companies within Accelerator Hubs, Universities and Hospitals.

In addition, one-day courses in specific subjects include:

  • Design Workshop. An interactive workshop to understand Design Control & to document the Design Inputs for your product.
  • Understanding ISO 13485:2016
  • Understanding the CE marking process
  • Understanding the UKCA marking process

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About Us

  • Richard Hall
  • Future Support
  • Gap Analysis & Due Diligence
  • Supplier Control

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