We support with the implementation of a suitable quality management system and the maintenance through an aligned audit program. The audit program covers internal audits and as well supplier audits. Our experts are qualified lead auditors and have extensive practical experience.  The customer requirements come in the first place to be able to deliver constantly high quality solutions.

Our services for auditing

  • Audit trails for (EN ISO) 13485, GMP and medical device directives worldwide
  • Supplier audits
  • Manage and respond to all medical device directives and EN ISO 13485 audits to rectify observed deficiencies
  • Development and implementation of compliance programs customized to company operations (e.g. QSR, MDD, ISO)
Dr. Albrecht Poth Business Development Medical Devices
+49 621 718858-0 send mail

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