With over 40 years of experience, and ISO 13485 consultants across the UK, our tailored medical device consultancy services provide support in implementing, maintaining and continually improving QMS management systems in line with ISO 13485.
We work with our clients on specific projects to help them address challenges in achieving ISO 13485 certification and put in place processes for continual improvement.
Completed projects include:
One of the first steps to achieving ISO 13485 certification is to assess how closely your current system meets the requirements of ISO 13485. This can be achieved by performing a gap analysis.
When undertaking a gap analysis our consultant will provide a full written report with the findings which can then be used to develop an ISO 13485 implementation plan.
Internal and pre-assessment audits help ensure your management system is effectively implemented and maintained.
Our medical device consultants can manage the entire audit process, from preparation and execution to delivering a detailed report outlining nonconformities and opportunities for improvement.
ISO 13485 requires organisations to develop documentation including a quality policy and document procedures such as procedures for the management review.
Our ISO 13485 consultants can provide support in creating and reviewing your documentation and provide guidance on additional documentation which can assist in the continual improvement of your management system.
Our medical device consultants will collaborate with you to assess your training needs and develop a tailored programme, ensuring your team has the in-house expertise to implement, audit, and continuously improve your QMS. Our training can also help you meet regulatory requirements such as MDR and IVDR while effectively managing risk with ISO 14971.
We offer ISO 13485 Lead Auditor and ISO 13485 Internal Auditor courses at venues across the UK, in our Virtual Classroom, and on-site at your premises. Dedicated courses can be customised to align with your specific requirements and integrate your company’s documentation for a more practical learning experience.
A certification audit assesses the extent to which an organisation conforms to ISO 13485:2016 requirements.
If nonconformities are identified, our consultants can support you in determining the root cause and implementing effective corrective actions. We ensure these actions align with ISO 13485 requirements, helping you achieve compliance and strengthen your quality management system.
If you would like to speak to someone about how we can support your organisation call our team on 0333 123 9001 or contact us.
Real Training Services Ltd|13th Apr, 2026
Abyssinia Iron and Steel Limited|7th Apr, 2026
Aqualution Systems Ltd|30th Mar, 2026
Swift Admin Solutions|24th Mar, 2026
Highway Assurance|23rd Mar, 2026
2gether Support Solutions|16th Mar, 2026
2gether Support Solutions|12th Mar, 2026
Canary Wharf Group Plc|11th Mar, 2026
Vinci Construction Management Ltd.|9th Mar, 2026
University Hospitals Sussex NHS Foundation Trust|5th Mar, 2026
Blu-3 UK Ltd|4th Mar, 2026
Roband Electronics Ltd|3rd Mar, 2026
We have worked with organisations across a range of industries from small UK based companies to internationally renowned organisations.
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Our interactive, tutor-led Virtual Classroom training allows delegates to up-skill from the convenience of their home or office.
View our range of CQI and IRCA certified Lead Auditor Training Courses including ISO 9001, ISO 14001 and ISO 45001.
Acquire the skills to plan, conduct, report and follow up an Internal Audit with training across a variety of standards.