Compliance with medical devices is our expertise. It is a long way from the idea of your product to market readiness. We support you along the way in implementing the legal requirements for market approval of your medical devices. We are experts in this and stand by you as a partner for the solution of your requirements. We open doors.
We offer the following services: EU Authorized Representative, CE Marking & EU Approval, International Registrations, MDR & IVDR Technical File, MDR & IVDR Compliance, Quality Management System, Audits & Inspections, Supplier Management, Computer System Validation, Article 15 Responsible Person, QMB Quality Management Representative, In-house Department Development.
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audits inspections, qmr quality management representative, ce marking eu approval, supplier management, eu representative, quality management system, international registrations, technical file according to mdr ivdr, computer system validation, development of company departments, person responsible for regulatory compliance acc to article 15, mdr ivdr compliance
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