Audit

ConsulTeam Medical provides none accredited 2nd and 3rd Party audit services with its expert auditors to the international medical device manufacturers. The staff is already registered as external resource auditor within international certification bodies. They provide value added audits for ISO 13485: 2016, EU Medical Device Directives (93/42 / EEC, 90/385 / EEC, 98/79 / EC), the new MDR, IVDR  and US FDA QSR – CFR Part 820.

The main purpose of the audit will be to prepare a detailed report with which manufacturers would have an opportunity to increase product safety and process effectiveness. Regulatory and selected standard requirements will be the main criteria for the audits. Please feel free to contact us at bizesorun@13485.info  for a GAP Analyses of your current quality management system about the revised requirements of ISO 13485: 2016