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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
Frame 1000005946

Scope of work

Done

Internal Audit for 21 CFR and ISO 13485

Done

Consulted on best format for their requirements

Done

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

Done

Performed quarterly

Done

Meet quarterly to discuss and host their Internal Audit

Done

Passed their certification audit with 0 non-conformities

Key numbers

Management

Team

1 auditor

Charity

Location

UK

Combo Chart

Length

12 months

WeChat

Type

WP1

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