Quality Assurance Services

Which of these do you need?

Most enquiries arrive as a situation rather than a service, so it may be easier to start from where you are.

You are applying for a licence

A first Wholesale Dealer Authorisation needs a quality system in place before the MHRA assesses it, and a named Responsible Person. That is WDA(H) support, usually alongside QMS design.

You have an inspection coming

A readiness audit tests whether the system does in practice what the documents claim, while there is still time to act. That is audit work, and where it finds gaps, GDP consulting to close them.

Your Responsible Person has left

An authorisation cannot sit without one. Interim or permanent cover is RP and RPi services, and the change itself usually needs a variation, which falls under WDA(H) support.

You make or supply devices

Quality system work against ISO 9001 or ISO 13485, including gap assessment and internal audit before a certification body sees it, is ISO consulting. Note that certification is granted by an accredited certification body, not by a consultant.

You had findings and need them closed

Remediation works when the corrective action addresses why the system allowed the gap, rather than restating the finding. Depending on where the gap sits, that is GDP or QMS work.

Not sure which applies? Describe the situation and I will tell you what it needs, including when it needs nothing. Get in touch.