We are proud to offer the following services.
To ensure better understanding of medical device regulations, Richard donates 1 day each week to train, coach and mentor individuals and start-up companies within Accelerator Hubs, Universities and Hospitals.
2. QMS - Quality Management System
A bespoke QMS, compliant to ISO 13485:2016, containing >60 procedures and associated forms can be fully operational within one week.
Richard has now helped his clients to pass more than 90 3rd party audits for ISO 13485, MDSAP, FDA & WHO.
3. TFT - Technical File Template
We have developed a 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.
QMS Consultancy
Richard Hall
richard@qms-consultancy.com