As a former Lead Auditor for a Notified Body, with experience from over 50 NB audits, Quality-Audit can support you with the following audit services.
Mock audits, Internal audits, Supplier audits, Due diligence audits
Compliance to the following audit requirements can be covered during the audit(s):
- Medical Device Regulation (EU) 2017/745
- EN ISO 13485:2016
- EN ISO ISO 9001:2015
- FDA 21 CFR 820
- Canadian Medical Devices Regulations (SOR/98-282)