- Life Sciences
Medical device testing
Certified testing to ensure maximum safety and quality for your medical devices.
Accurate and reliable testing of medical devices.
Our testing services for medical devices guarantee their safety and quality. We offer a comprehensive range of services, including mechanical testing, aging tests, validation, and verification, all in accordance with international standards such as ISO, EN, and DIN. Utilizing state-of-the-art technology and a highly experienced team, we ensure full compliance with regulatory requirements, supporting you from product development through to approval.
Overview of our services
Mechanical Testing: ISO 17025, ASTM
- Planning and assessment of mechanical requirements
- Definition of acceptance criteria
- Worst-case analysis
- Evaluation of test resultsStatic and Dynamic Testing: ISO 17025, EN 45502, ASTM F543
- Conducted according to current standardsAging and Preconditioning: ISO 11607
- Tests for accelerated aging and preconditioning of devicesSyringes and Needles: ISO 9626
- Testing for rigidity, breakage resistance, and corrosion resistanceDrug Delivery Systems: ISO 11608
- Testing for combination productsSurgical Instruments: ISO 7153-1
- Mechanical safety and performance testingPackaging: ISO 11607
- Testing of packaging for sterile medical devicesRegulatory Affairs: ISO 14971
- Preparation of technical documentation
- Clinical evaluations
- Risk analyses
Our Experts:
The industries:
- Life Science
- Pharma
- Medical devices
- Scientific community
- Food / agri Producers
- Chemical
- Manufacturing