Background

The goal of this event is to learn about laws, authorities’ guidance documents as well as about historic establishment of testing standards until up-to-date standard testing of today’s medical devices.  This one-day IIIOS training event will cover the following topic: and educate each attendee as a “Specialist for Medical Device Regulation and Testing”:

• Medical Device Directive, Laws, Guidance documents (Dr. Rudorf, TUV South Product Service, Germany)
• Risk management ISO 14971 (Dr. Engels, MR Safety Consultant, MR:comp and former MR Safety Director Philips Healthcare, The Netherlands
• Standardized Testing for Medical Devices
• Biocompatibility Testing (Dr. Albrecht, BSL, Germany)
• Hygiene Testing and Sterilisation (Dipl.-Ing. (FH) Bertsch, Redis, Germany)
• Re-Sterilisation (Dipl.-Ing. (FH) Bertsch, Redis, Germany)
• Ultrasound (N.N.)
• Radiopacity Testing (Dipl.-Ing. (FH) Schaefers, MR:comp, Germany)
• MR Safety and Compatibility Testing (Dipl.-Ing. (FH) Schaefers, MR:comp, Germany)

 

Schedule

Start	Lecture Title	Lecturer
08:00	Welcome Reception/Breakfast
08:30	Medical Device Directive, Laws, Guidance Documents	Hans-Guenter Rudorf
09:35	Risk Management ISO 14971	Hans Engels
10:20	Coffee Break
10:35	Biocompatibility Testing	Achim Albrecht
11:40	Hygiene Testing and Sterilisation	Thomas Bertsch
12:40	Lunch Break
13:40	Re-Sterilisation	Thomas Bertsch
14:15	Ultrasound	Sandy Cochran
15:15	Coffee Break
15:30	Radiocapacity Testing	Gregor Schaefers
16:00	MR Safety and Compatibility Testing	Gregor Schaefers
17:00	Discussion
17:30	Meeting Close

 

Essential Information

Date:                           June 7th 2011   (08.30-17.30)

Venue:                        IMSaT, Dundee

Target Audience:       Medical device manufacturers, regulatory agencies, researchers. Priority will be given to IIIOS fellows.

Cost:                   

£30 IIIOS funded rate for students

£300 for researchers (university or public institute based)

£500 for industry and private organisations

 

Hosts

MR:comp GmbH -www.mrcomp.com

MR:comp GmbH is specialized in testing implants, instruments and accessories regarding to MR safety and compatibility for device use within the MR environment. Standardized test methods are use for assessments such as the measurement of magnetically induced displacement force (translational force) and torque and of RF and gradient induced effects, as well as MR image artifacts by device materials/electromagnetic coupling. MR scanners are available from 0.2 to 7.0 Tesla. Research services are provided in the field of numerical simulation of electromagnetic fields analysing MR characteristics and RF-induced heating

 

IIIOS Network - www.IIIOS.eu

IIIOS is an Initial Training Network funded by the FP7 people programme, composed of ten main partners.  Its goal is to develop novel techniques and devices to meet the needs of the imaging operating theatre, including: Introducing multimodality, non-invasive, image-guided diagnosis techniques, Developing therapy based on MRI, ultrasound and biophotonics for cardiovascular procedures and cancer treatment and combining macroscopic MR, CT and PET imaging, ultrasound and microscopic biophotonics with existing techniques for minimally invasive interventions and  surgery

 

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