About QMS Consultancy
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 40 companies to develop more than 60 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 70 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 Liverpool.
Employing a full time Quality Manager is often impractical and too expensive for a small company, that’s where we can help, offering a tailored service to match the needs of our clients. Some companies have existing resource with sufficient understanding and abilities and are able to become independent in a short length of time, while others need more help. Following installation of your QMS or TFT, ongoing support in the future will depend on your own business requirements and staffing levels. This can range from a weekly on-site contracted Head of Quality role, to less frequent support just when its needed. Alternatively, mentoring and training of an existing staff member who is responsible for Quality within your organisation can often be the favoured support method. Support from QMS Consultancy can be provided by email, phone or Zoom calls on an ongoing basis.
With experience of more than 70 Notified Body audits (ISO 13485, MDSAP, FDA GMP, WHO & CE marking), Richard can provide consultancy to ensure you are ready for these important audits. Often clients require QMS Consultancy to act as Head of Quality during such audits.
It is worth noting that the EU MDR/IVDR (ref. Article 15) require all medical device companies to employ a 'Person Responsible for Regulatory Compliance' and that it is permissible for this to be an outside contractor.
Ongoing support activities may include:
- Writing Technical File documents
- Management of CAPA and Change Control for product improvement actions, customer complaints and Vigilance issues.
- Control activities for Suppliers or Subcontract Manufacturers including Quality Agreements and Supplier Audits
- Internal Audits
- Running Management Review Meetings
- Development of specifications for materials and/or product
Gap Analysis & Due Diligence
From working within the medical device industry since 1993, Richard has gained a large breadth of experience, enabling him to quickly identify gaps in current company processes. He has hands-on experience of the following aspects of medical device manufacture:
- Supplier Management, including supplier audits
- QC, QA, Regulatory Affairs
- ISO 13485 (& associated harmonised standards)
- Medical Device Directive & Regulation (93/42/EEC & EU 2017/745)
- In Vitro Medical Device Directive & Regulation (98/79/EC & EU 2017/746)
- CE Marking and Device Technical Files and
- Internal, External and Notified Body Audits
We can therefore perform gap analysis for the companies themselves or due diligence on behalf of third party organisations on the following topics:
QMS Gap Analysis
- An investigation into the existing QMS, and its conformance to the requirements of ISO 13485:2016
TF Gap Analysis
- Examination of existing medical Device CE Technical Files and their conformance to the MDD / MDR, IVDD / IVDR & the UKCA Mark
Contact us today to see how we might help you!.