Medical Device QMS Consultancy

ISO 13485 gap analysis

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.

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Auditing against ISO 13485

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.

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Developing documentation

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.

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Medical devices training programme

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.

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Nonconformities & corrective action

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.