QMS Consultancy Ltd

Richard Hall

Overview

QMS Consultancy is an independent consultancy firm offering advice, mentoring, tools and resources to help start-ups and entrepreneurs to understand and comply with the medical device regulations.

The company is ran by Richard Hall, who has worked in QA, QC, Development and Regulatory positions within the Medical Device and IVD industry since 1994. For 20 years he worked with multi-national organisations and now focusses on medical device start-up companies, helping them with new product development, gaining ISO13485 certification and Regulatory approval for their products.

Richard has created a program for implementing bespoke ‘Drop-In Systems’ specifically designed for medical device start-ups. The system uses proprietary software to enable an ISO 13485 compliant QMS and a CE Technical File Template to be implemented incredibly quickly allowing his clients a faster route to market.

Named as inventor on two patents, Richard thoroughly understands the process of new product development and holds an Expert In Residence position at the University of Oxford & Imperial College London where he lectures in the field of Medical Device Regulations.

Richard now donates every Wednesday to helping start-ups, clinicians, entrepreneurs and academics to better understand the regulatory requirements for medical devices and IVDs (including software).

Services we offer

  • Free verbal advice
  • Design Workshop
  • Technical File Template
  • Quality Management Systems compliant to ISO 13485, FDA, WHO and MDSAP, ISO 15189

Support we offer

  1. Almost unlimited free verbal advice and mentoring to help you understand the MD Regulations and how to comply with them.
  2. Two day Design Workshop: Sets the foundation and creates 5+ fundamental documents for your device Technical File. By the end of the workshop you will have documented a Use Specification, the User Needs, Design Inputs, Hazards and a Risk Assessment. These core documents are held together by a Traceability Matrix that acts as your Master Validation Plan, ensuring you know what must be completed before launch.
  3. TFT: A Technical File Template, containing 80+ documents. This set of formatted and part-complete documents are designed to save you hundreds of hours when pulling your product Technical File together.
  4. QMS: A tailored Quality Management System. The QMS has already passed >85 audits from the likes of BSI, DEKRA, FDA, MDSAP, WHO.

The above services are provided with on-site training to ensure they are fully understood and quickly implemented.

Eligibility criteria

QMS Consultancy specialises in working with medical device start-ups. We can cover MD, IVD & MDSW companies.

If you have a product under development or just an idea and you are wondering which direction to turn, we can help.

Funding

I am happy to review grant bids that include my services to ensure they are worded accurately and I am happy to speak to investors to help support VC bids.