YOUR SAFETY IS OUR JOB
Medical device testing is a crucial step in the process of transforming an innovative design into a reliable and saleable product.
We offer the right solutions for mechanical and technological testing in the medical and pharmaceutical industry. To set up your laboratory efficiently and effectively, we can offer you flexible and modular systems in terms of machines, testing devices and software.
We combine the knowledge of product testing experts, providing you with a complete solution. Our testing facilities subject your product to a comprehensive evaluation of the medical device industry and help you demonstrate compliance with standards and regulations worldwide.
In the dental industry, materials (ceramics and metals), composites, and adhesive bands are tested and the fatigue strength of dental implants is determined.
Biomechanics deals with the functions and structures of the musculoskeletal system and the movements of biological systems.
Medical and pharmaceutical products must be packaged securely and ensure product safety over an extended storage period.
A significant element of process validation in the medical and pharmaceutical industries is the technical review of individual systems and devices. This qualification is also applied to STEP Lab test systems used in these sectors, which are subject to various legal requirements (e.g. Medical Device Directive 93/42/EEC or regulations such as FDA 21 CFR Part 11 and EU GMP Guideline All. 11). STEP Lab supports its customers in the DQ, IQ, and OQ qualification of material test systems by providing comprehensive and tailor-made documentation by GAMP5 and applicable guidelines, and by carrying out the actual qualification procedure on site.
- Unique test management software
- Designed to work together or alone.
- A team of experts is always at your disposal
- Customized design according to your needs
- Products that are easy to assemble and maintain
- We are the first carbon-neutral company