Quality management
Quality starts with putting customer satisfaction at the centre of all considerations
Intensive dialogue with our international customers is a prerequisite for acting in line with market and using state-of-the-art technology. We analyse the needs of our customers and initiate industry trends and innovations that help improve healthcare worldwide.
Top Performances achieve targets
Since our products are used directly on patients and in the most modern research and development laboratories, they must conform to the highest safety, precision and hygiene standards. As a global company, we can ensure that our products meet the statutory and official regulations of various countries and markets.
Against this background, Sarstedt has introduced an integrated Quality Management (QM) system. It is based on the international standard EN ISO 13485. Independent bodies regularly monitor and certify compliance with standards.
IVDR-certified quality – for safe and precise solutions
SARSTEDT is transitioning to IVDR step by step: Since May 2022, all non-sterile Class A IVD products have been certified. By the end of 2024, the certification of our Monovette product line and transfer pipettes under IVDR was completed. In the coming months, the gradual transition to IVDR-compliant labeling will take place. Until then, the products remain available under IVDD. For sterile Class A products, such as Monovettes and transfer pipettes, a transition period applies until the end of 2029. Other sterile Class A products are currently undergoing certification. We are adapting these products in a timely manner to meet IVDR requirements.
MDR-certified quality – for future-ready solutions
All SARSTEDT medical devices have been certified under the Medical Device Regulation (MDR) since April 2023 and have been marketed as MDR-compliant since September 2023. We chose not to use the extended deadline, which allows Class Is and IIa medical devices to be marketed under the MDD certificate (Directive 93/42/EEC) until the end of 2028. Instead, we proactively took all necessary steps to ensure the highest standards of safety and quality, as well as uninterrupted availability.
Our claim: care and safety
In order to ensure the highest possible level of quality, we pursue various different strategies at all levels. In doing so, we always use state-of-the-art production facilities and high-quality raw materials. We always guarantee a consistently high level of quality by using standardised processes and constantly monitoring and analysing these.
In addition, we have developed our own seals of quality. For example, the label "Biosphere® plus" is a purity standard for laboratory products. Additionally, our other certifications "PCR Performance Tested", "TC Tested" and "Cryo Performance Tested" document our guarantees for purity and highest quality.
SARSTEDT quality means meeting the highest requirements.
