The demands on medical technology are as diverse as the products themselves. Standards such as ISO 13485, legal requirements (EU directives, CFR Part 820, GMP) and our own quality requirements define the standards whose compliance is checked by authorities and customer audits.
As a full-service provider with highly trained employees and high-precision measuring equipment we support you in securing your quality standards. In peak times or for larger projects, we provide you with flexible manpower with the appropriate know-how. We pay attention to a cost-sensitive implementation of your wishes and requirements.
Product idea: We support you with development documentation in compliance with standards and laws as well as with design verification and validation.
Implementation: We ensure the transfer of the design to production with initial calibration of your test and measurement equipment, qualification of your systems and validation of your processes.
Production: We regularly calibrate your test and measurement equipment and periodically check your systems for qualified status. In addition, with PRIMAS we offer you an integrated solution for your test equipment management.
Quality: We take over tasks like change control, deviation management or GAP analys<s>es</s>is and thus relieve your quality assurance. In addition, we validate your automatic measuring devices and carry out gauge capability studies for you. In this way we support you in ensuring the conformity of your sales products in quality control.
For you, this means minimum effort with maximum security: low support and coordination effort and, at the same time, reduced costs through tailor-made solutions and single-sourcing. We provide individual support for our customers in the medical technology sector in the areas of research & development, production, quality assurance and quality control – just contact us.
For our medical technology customers, we realize a wide variety of tasks. These include, for example, the calibration of test equipment of various measured variables (e.g. thermodynamics, pressure or dimensional) in our laboratories and on site, clean room measurements (e.g. filter measurement, clean room classification measurement, recovery time measurement) and climatic cabinet measurements on site. We also carry out plant qualification of new and existing plants, computer and software validation or process/cleaning validation. We create design history files or concepts to increase cGMP compliance and carry out GAP analysis for you – always individually according to your needs.
A selection of the companies we work with in the medical technology industry:
The company was supported in the creation of a cross-location concept to increase cGMP compliance, including the pragmatic integration of existing documentation into the new GMP concept. Furthermore, the company was supported in consulting, structuring and implementation of comprehensive activities in the compliance areas of qualification, process validation, cleaning validation and validation of analytical methods.
The Richard Wolf company is certified according to DIN EN ISO 13485 and professional test equipment management is essential to maintain the standard. This includes: Calibration, documentation, IT (web-based access to master data), logistics (pick-up and delivery service) and the complete organisation of calibration services with deadline monitoring with a fixed contact person at Testo Industrial Services.
In the context of a production expansion, a GMP-compliant qualification of clean rooms became necessary at Hartmann. Testo Industrial Services took over the conception of the scope of measurement according to DIN EN ISO 14644, the evaluation of the measuring points, the creation of the qualification plans as well as the practical execution of the clean room measurements.
A single-sourcing solution was established for the company for the administration of test equipment from Germany, USA, China and Poland as well as the calibration of test equipment from Germany and Poland. For this purpose the gauge data of more than 5,000 gauges including calibration cycles and escalation scenarios were transferred to the PRIMAS online system.