Medical Device Testing
Get your certificates for US and Europe market with high quality recognized medical device testings. Profit from very short delivery times for chemical characterization or chemical cleanliness.
It is a must to perform ISO 10993-18 chemical characterization and ISO 19227 chemical cleanliness testings on medical devices to enter the US and EU market. NIUTEC AG knows the requirements of the notified bodies and keep the analytical procedure continuously updated.
Chemical characterization ISO 10993-18
With the new Medical Device Regulation (MDR), the demands placed on manufacturers are increasing. For example, comprehensive technical documentation is required and proof of biological safety (biocompatibility) is a prerequisite for the approval of your medical devices.
For this reason, Niutec develops test strategies in accordance with ISO 10993-12, ISO 10993-15 and ISO 10993-18 with subsequent toxicological evaluation in accordance with ISO 10993-17.
Cleanliness ISO 19227
Medical devices come into contact with various process auxiliaries during their manufacturing process. This can result in the development of critical substances that are hazardous to health. These hazardous substances accumulate, for example, in surface structures and blind holes, they adhere as a thin film to product surfaces or penetrate plastic parts.
With the new medical devices regulation (MDR), the demands placed on manufacturers are increasing. With our targeted cleanliness tests, you can provide efficient and meaningful evidence of the cleanliness of your medical devices.
Your advantages, our strengths
• Accredited and independent laboratory
• Easy and quick order placement
• Clear and understandable test reports
• Short delivery time
• Direct contact with experts
• Many years of experience in consultation of production processes and risk assessment in medical technology
• Advice on the selection of analyzes
• Seminars, workshops and in-house training courses on the topic of cleanliness and chemical characterization
Why NIUTEC AG
As a Swiss laboratory, we attach great importance to high quality. Our very clear reports and the extensive know-how behind the analysis process create trust among our global customers. Let us have a free call to discuss your actual project.