Services

Management systems

• Management systems tailored to customer requirements
  in accordance with ISO 13485 / ISO 14001 / FDA QSR
• Carrying out internal audits and supplier audits

QM/UM/RA support 

• Outsourcing of quality and environmental management functions (PRRC, QMB, UMB)
• Support for CAPAs and remediation of audit vulnerabilities
• Implementation of PMS and vigilance activities
• Evaluation and verification of AI tools for quality and regulatory topics

Medical devices

• Preparation of technical documentation in accordance with MDR and 510(k)
• Change management / PFAS changeover
• Support with risk management, validation and biocompatibility
• Support with approvals, registrations and communication with authorities and notified bodies

Needs-oriented support

Our services are based on close cooperation with our customers.

We listen, understand their needs and support them pragmatically and competently exactly where necessary.

Whether project management, coaching or document creation - we are there for you and accompany you on your path to success.

" Only those who have walked the path themselves know the shortcuts. "