
Quarterly Internal Audits
Introduction
Quarterly Internal Audits
Our client is a start-up medical device manufacturer of a body cooling device, for those with heat stroke. They are based in the UK and are undergoing ISO 13485 certification.
Standards & Tools
- 21 CFR
- ISO 13485
- MDSAP
- MDR

Scope of work

Internal Audit for 21 CFR and ISO 13485

Consulted on best format for their requirements

Hosted by one of Apotech’s ex-notified body technical assessors

Performed quarterly

Meet quarterly to discuss and host their Internal Audit

Passed their certification audit with 0 non-conformities
Key numbers

Team
1 auditor

Location
UK

Length
12 months

Type
WP1