Offering quality assurance in medical engineering

Quality assurance in the medical engineering and pharmaceutical industry places the highest demands on testing technology in terms of hardware, software, and documentation.

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 minimise risk to patients and users.

ZwickRoell offers the optimum solutions for mechanical and technological tests in the medical and pharmaceutical industries. It offers a flexible, modular system of machines, specimen grips, and software to equip laboratories efficiently and economically. The portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopaedics and biomaterials.

An 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) which is available for ZwickRoell's testXpert lll 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 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 has the tools needed to meet requirements of the medical device industry, from cleanroom requirements, DQ, IQ, & OQ qualification, Expanded Traceability for test results, and systems for climate and temperature testing.