Quality assurance in the medical and pharmaceutical industry places the highest demands on testing technology in terms of hardware, software, and documentation.
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Laws regulate the medical and pharmaceutical industry
This industry is heavily regulated by laws and regulations. That is why safety requirements are even more stringent than in most other industries, especially since these products—from injection pens and implants to sterile packaging—directly impact humans. Quality control that meets these requirements comprises not only development, production, and packaging of medical and pharmaceutical products in compliance with the legal framework and applicable standards, but must also minimize risk to patients and users.
ZwickRoell offers the right solutions for mechanical and technological tests in the medical and pharmaceutical industries. We offer a flexible, modular system of machines, specimen grips, and software to equip your lab efficiently and economically, saving you time and money. The extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopedics and biomaterials—there isn't a test task that we can't handle.
An ever-increasing demand is placed on software used in the medical and pharmaceutical industries to document the traceability of completed actions. These demands are met by the Expanded Traceability (as per FDA 21 CFR Part 11) option available for ZwickRoell's testXpert III testing software, optimally supporting the operator with test tasks.
A significant element of process validation in the medical engineering and pharmaceutical industries is the technical review of individual plant and devices. This qualification is also required for ZwickRoell materials testing systems used in the medical engineering and pharmaceutical industries, because systems are subject to various legal requirements (for example, under Medical Devices Directive 93/42/EEC or regulations such as FDA 21 CFR Part 11 and EU GMP Guideline Annex 11). ZwickRoell provides support for customers in the DQ, IQ and OQ qualification stages for materials testing systems in the form of comprehensive, individually tailored qualification documentation in accordance with GAMP5 and current guidelines, and during the actual on-site qualification procedure.
ZwickRoell’s answers to special requirements in the field of medical engineering
ZwickRoell has all the tools needed to meet requirements of the medical device industry—from clean room requirements, DQ IQ OQ qualification, Expanded Traceability for test results, and systems for climate and temperature testing.
If you are looking for the optimal solution for each of your requirements, please contact our industry experts.
We look forward to discussing your needs.