Medical Device Quality Management System (QMS)
Medical device companies intending to place medical devices on markets such as the UK, EU and US are required to operate a suitable Quality Management System (QMS). ISO 13485 is the standard harmonised in the UK and EU, and recognised in the US, meaning it is crucial your QMS complies with this standard for you to demonstrate your compliance.
Our Process
- Free initial consultation to discuss your needs.
- Creation of a plan tailored to your specific company and product requirements.
- Customisation and implementation of QMS documentation.
- Training and audit preparation for relevant staff.
- Stage 1 audit.
- Stage 2 audit.
- Certification!
- Continuous support to ensure ongoing compliance.
Example QMS Documents
- Quality Manual
- Standard Operating Procedures (SOP)
- Templates and Forms
Alan Finnerty, Principal Consultant, has participated in over 40 EU Notified Body and UK Approved Body QMS audits, acting as lead auditee in more than 20. This depth of hands-on experience across the planning, implementation, certification, and ongoing maintenance of ISO 13485 and FDA-compliant QMSs enables start-ups and scale-ups to achieve certification efficiently, pragmatically, and with confidence, while aligning with product development, regulatory submission, and market launch timelines.
Contact us
If you are considering implementing a Quality Management System (QMS) in your MedTech company, call us on +44 (0)7891 357172 or email us at info@xiomed.com to arrange a free initial consultation.