ISO 13485 Medical Devices Quality Management System Consultancy

The requirements fall into four buckets: define it, document it, run it long enough to generate records, then audit it yourself before the certification body does.

Two to four months is the honest range for most organisations, measured from gap analysis to the certification audit. What moves it is how much you already document, how quickly people can be released for training, and the certification body's own diary.

No, and no consultant should. The certificate comes from an independent accredited certification body after their own audit. We prepare you to pass it and we are there on the day to close findings. That separation is exactly what makes the certificate worth holding.

We price per engagement rather than per seat, because a single site business and a five site group need very different amounts of work. You get a written proposal covering scope, audit days and fees before committing to anything.

We map ISO 13485 to 3 sectors and it sits in our medical devices practice. Organisations usually arrive because a specific buyer, regulator or tender committee has asked. Tell us who is asking and we will confirm whether this is the standard that satisfies them.

Both, and hybrid. Gap analysis and audit day usually benefit from someone physically present, while documentation and training work perfectly well remotely. We fit delivery to your sites and schedule rather than the reverse.