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
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