«Identifying the problem is more important than finding the solution. The exact statement of the problem leads to the solution.»

QUALITY MANAGEMENT SYSTEMS AUDITING IN MEDTECH

We are your auditors with expertise and social competence. We audit efficiently and according to standards and legal requirements. Our association with auditees is factual and respectful.

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The following kinds of audit are our business:

• internal audits

• supplier audits

• audits by order of the certification body Swiss Safety Center AG

Outsourcing audits to us has the following benefits:

•  The auditor is chosen subject-specifically

•  The auditor has long-term audit experience from countless audits and various companies

•  The auditor is independent of the audited company and its employees

If there are critical reasons for an audit, i.e. nonconformities or shattered human relations, we as independent auditors will find easier access to the auditee.

We audit the compliance to the following laws and standards:

• Quality Management Systems according ISO 9001, ISO 13485, EN 14065 or EN 17025

• Swiss Medical Device Ordinance MepV 812.213

• EKAS Directive 6508 for safety at workplace

• European Medical Device Regulation 2017/745 MDR

• FDA 21 CFR part 820 Quality Management System Regulation QMSR

• Canadian Medical Devices Conformity Assessment System CMDCAS

• Medical Device Single Audit Program MDSAP