QMS Consultancy Ltd

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).