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.
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 your business and fulfils all the requirements of ISO 13485:2016.
Richard has now helped his clients to pass more than 85 Notified Body audits for ISO 13485, FDA, MDSAP & WHO.
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 >80 documents that are numbered, structured, semi-complete and bespoke to your company, can be provided within one week!
Our mission is to build transparent, fully integrated and compliant Systems that support all aspects of business function, from new product development through launch and beyond.
Richard has worked in the medical device industry since 1993 and has held senior management positions within New Product Development, QC, QA and Regulatory Affairs. Since founding QMS Consultancy in 2014, Richard has helped over 60 companies to develop more than 100 medical products including medical devices from Class I – III & IVD’s from Class A – D and is named as inventor on two patents.
Richard has written numerous product technical files and has been successful in gaining regulatory approval for multiple medical devices.
As a trained lead auditor, Richard knows exactly what is necessary for a successful audit and has been the company contact for more than 85 notified body audits, the support he can offer throughout the audit process is invaluable.
Richard lectures at Imperial College London on Medical Device Regulations and holds an Expert In Residence position at the University of Oxford and Imperial.