Innovationen für die Medizin

Risk Management Assessment
No approval procedure for medical devices without it

This course is one out of seven continuing education courses at the World Congress 2009 organised by the VDE|DGBMT and the Forum MedTechPharma.

We look forward to seeing you in Munich.

Link to the registration

Link to the course overview

Program "From Science to Innovation" (pdf)

Course Instructors

Johannes Dehm, Dipl.-Ing.

• Managing Director of the VDE Initiative MikroMedizin (MicroMedicine), Frankfurt/Main
• Management functions in different organizations of the VDE in electrical engineering, medical engineering and telemedicine
• Studies in electrical engineering, communications technology at the University of Applied Sciences Frankfurt

Michael Bothe, Dipl.-Ing., MBA

• VDE Institut, Offenbach
• Responsible for systems/processes of medical engineering
• Activities in technology, quality and innovation management
• Studies in communications engineering at the TU Braunschweig

Peter Knipp, Dipl.-Ing.

• Founder and Managing Director, qcmed Quality Consulting Medical GmbH, Aachen & Bonn
• Coach TÜV-Rheinland / LGA
• Until 2006 Partner of LINEA GmbH, business areas: quality management, approval of medical devices, test laboratory for cardiovascular implants
• Studies of mechanical engineering (Dipl.-Ing.) at the RWTH-Aachen

Training Material

A full risk assessment is part of the approval procedure for medical devices! Every producer of medical devices and in-vitro-diagnostics is compelled to establish the process specified in the DIN EN ISO 14971:2007, as well as fulfill the CE labeling according to

• the Active Implantable Medical Device (AIMD) Directive - 90/385/EEC,
• the Medical Device Directive (MDD) - 93/42/EEC,
• the In Vitro Diagnostic Device Directive (IVD) - 98/79/EC

and the FDA admission.

The risk assessment not only includes an analysis of construction, applied materials, energy flows, bio-compatibility, infection and cross-infection risks and many other product/system properties, but also assesses the way the risks of the product/system are managed within the organization. The measures have to be implemented in all phases of the product's life cycle. This also means that university institutes, research institutes and SME's doing basic research for medical device manufacturers have to implement risk assessment.

Participants will learn how to implement risk management as an intrinsic part of the development process for medical devices, which is prerequisite to successful approval procedure according to the European, U:S: and other worldwide regulatory systems. The course will present hands-on risk management methods and procedures including FMEA (Failure Mode and Effect Analysis) and a bi-directional TOP-DOWNTOP FTA (Fault Tree Analysis) method. The course will conclude with the application of risk management in case studies submitted by the audience.

Participants

Registration fee