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Approving Medical Devices and GMP-Audits

My name is Conrad Julius and I am an expert in medical devices and GMP audits. My job is my vocation. Consulting on complex topics in the field of medical devices and conducting audits worldwide has become my passion in recent years.

I support you with all regulatory requirements, from the assessment of biocompatibility to the implementation of the necessary tests. Furthermore, I support you in the current exciting time of the changeover from MDD to MDR in order to make your medical devices compatible for the European market.

I am a member of the ISO/TC 194 (various working groups) and DIN NA 027-02-12AA committees and participate in various regulatory committees that develop standards, discuss biocompatibility methods and vote on changes to these standards.

In the area of audits, as a lead auditor, I offer you the opportunity to carry out GMP audits for your suppliers worldwide. From the planning to the audit itself, the creation of the reports and CAPA plans to the follow-up of the downstream document monitoring, the service includes the complete process of your supplier qualification from a single source.