Internal audit

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Internal audit and ISO 13485

MD101 is able to carry out audits on various standards with auditors qualified for :

  • ISO 13485
  • 21 CFR part 820
  • Règlement UE 2017/746
  • Règlement UE 2017/745
  • MDSAP (tous pays)

We recommend to carry out an initial internal audit after a quality system has been set up, and before it is audited by a certification body, in order to check its compliance with normative and regulatory requirements. Internal audits also help prepare your teams for certification audits.

ISO 13485 requires medical device manufacturers to monitor and evaluate the effectiveness of their quality management system by carrying out internal audits. These audits can be carried out by a third party with the required qualifications and skills to conduct an audit, and who can provide an outside view of the quality system in place, with a view to continuous improvement.

– Three-year commitment possible
– 1 qualified auditor
– 1 detailed report

MD101, co-founder of the .emt Alliance

United to support companies in HealthCare

MD101, co-founder of the .emt Alliance

MD101, founding member of The MedTechAlliance, USA

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MD101, founding member of The MedTechAlliance, USA