Medical Device Consulting

            • Regulatory Affairs
            • Quality & Risk Management 
            • Project Management
Grübling Medical Device Consulting Project Management

Project Management

  • General Project Management
  • Development Project Management
  • Certification Project Management
  • Project Planning
  • Project Controlling
Grübling Medical Device Consulting Quality Management

Quality & Risk Management

Definition and Implementation of Quality  and Risk Management Systems (ISO 9001, ISO 13485, ISO 14971, Joined Commission International).

Internal, external and supplier audits.

Grübling Medical Device Consulting Regulatory Affairs

Regulatory Affairs

  • MDD 93/42/EEC and MDR EU 2017/745
  • IVDD 98/79/EC and IVDR EU 2017/746
  • Clinical Evaluation
  • PMS / PMCF
  • Standards (IEC 60601-1, IEC 62304, IEC 62366 …)
Phone-alt Envelope Linkedin-in Xing