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Press Selection
viewpoint 03/2003 Carl Zeiss Meditec
Workshop on the standards
of the American Health Authorities
Lufthansa Magazin 5/2003
www.kompetenznetze.de - Feature - Jena region
The Home of Innovation
AHK - MGCC Quarterly September/October 2001
The Business Magazine of the Malaysian-German Chamber of Commerce and Industry
New methods for excellent eyesight
Medical Technology for Ophthalmology
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Press
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viewpoint 03/2003 Carl Zeiss Meditec
Workshop on the standards of the American Health Authorities
The association "Ophthalmo-Innovation in Thüringen e.V. (OIT)" held a one-day workshop in Jena in association with Carl Zeiss Meditec.
Forty participants from various institutions and companies from the region received information about the extremely high standards
and strict controls applied by the US health authority, the Food and Drug Administration (FDA).
As the USA represents the largest market for medical equipment, including instruments and systems for ophthalmology,
the importance of this matter cannot be overestimated. Carl Zeiss Meditec supplied the speakers and contributed its own
experience in the field. The workshop covered the following aspects:
- Standards for licensing of medical equipment in the various regions of the world compared to those
of the FDA, and an explanation of the terms used in the American licensing process, e.g. CFR, PMA, 510(k) etc.
- Standards for the design of medical equipment and the associated risk management considerations. Although
this section only accounts for a small part of the provision, it has far-reaching consequences in practice.
- Standards for software development. With our instruments and systems, too, software is becoming increasingly important,
and the US health authorities are giving this subject a lot of attention at the moment. The
requirements for process quality and documentation during the development stage, from validation through verification,
module tests and source code, are very tough indeed.
- Corrective und Preventive Action (CAPA). This is an all-embracing system that records and evaluates all actual or potential malfunctions
not just in instruments but also in processes, takes the necessary preventive action, then documents and archives them. It all contributes to
constant quality improvements for a company´s equipment and processes.
The workshop was rounded off by group exercises demonstrating with practical examples how complex and demanding it is to meet the FDA standards, even
if they sometimes sound quite simple at the outset.
Ophthalmo-Innovation Thüringen e.V. promotes contact between scientific institutions and medical equipment manufactures specializing in ophthalmology
in the German state of Thuringia. Carl Zeiss Meditec is a member of the association and has already implemented a number of succesful technological developments with it.
Report by Martin Wiechmann
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