BÜHLMANN Laboratories AG
BÜHLMANN is a fully independent, medium sized and family owned Swiss company. The company was founded in 1976 and has continuously developed over the years. BUHLMANN continues to renew and enlarge its product port and in combining innovation with its traditional core values aim to be a leader in selected fields of in vitro diagnostics. Quality is not just a statement, but part of our daily commitment- The Management System is EN IS013485:2016 certified and the products are manufactured according to GMP standards. BUHLMANN staff and distributors as well as selected customers are continually trained. BUHLMANN is known for the outstanding quality of its products, its excellent after sales services and a worldwide availability through a network of highly qualified distributor
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Monitoring
- Market Focus:
- Globally (various continents)
- Year Founded:
- 1976
Our Values
Unique
BÜHLMANN has become the prime calprotectin company within a few years, offering the broadest calprotectin product range with the automatable BÜHLMANN fCAL® ELISA and the quantitative Quantum Blue® Calprotectin rapid tests and the new immuno-turbidimetric BÜHLMANN fCAL® turbo assay. For automation on ELISA robots we will continuously offer new CE-marked protocols for our BÜHLMANN fCAL® ELISA, combined with our easy, safe and clean stool sampling and extraction CALEX® Cap device. With IBDoc® calprotectin, the smartphone based home testing solution, BÜHLMANN is bringing calprotectin monitoring to patients. In 2016, BÜHLMANN has launched its newest innovation the Quantum Blue® Infliximab rapid test allowing clinicians immediate determination of trough levels.
BÜHLMANN does not only stand for calprotectin, but also for a selection of unique, high-quality assays for clinical routine use such as the BÜHLMANN Flow CAST® product group for Basophil Activation Testing, and the BÜHLMANN GanglioCombi™ MAG ELISA , the only screening ELISA for anti-Ganglioside and anti-MAG antibody testing in one single assay.
BÜHLMANN continues to renew and enlarge its product portfolio, with the aim to be a leader in selected fields of in vitro diagnostics and in combining innovation with its traditional core values.
As unique as our products are our distribution fields with leading suppliers in the field of molecular diagnostics. With Seegene and the Anyplex™ II/Allplex™ products in combination with NIMBUS IVD/STARlet and the CFX96, we offer the leading automated high multiplex real-time PCR solution, with a unique menu, for all sizes of laboratories. With EntroGen we offer outstanding MDx tests in the field of Oncology.
Reliable
Quality is not just a statement, but part of our daily commitment. The Management System is EN ISO 13485:2016 certified and the products are manufactured according to GMP standards. BÜHLMANN staff and distributors as well as selected customers are continually trained.BÜHLMANN is known for the outstanding quality of its products, its excellent after sales services and a worldwide availability through a network of highly qualified distributors.
Independent
BÜHLMANN is a fully independent, medium sized and family owned Swiss company. The company was founded in 1976 and has continuously developed over the years. Sister companies have been established in Austria (BÜHLMANN in Austria GmbH) in 1996, in France (BÜHLMANN France SAS) in 2002, in Italy (BUHLMANN Italia srl) in 2009 and Brasil (BÜHLMANN Brasil) in 2013. In 2015, BUHLMANN Diagnostics Corporation has been established to serve customers in the USA and Canada. Since 2005, BÜHLMANN products are directly distributed in Germany.Quality Statement
BÜHLMANN Laboratories AG, as manufacturer dedicated to serving the life science and In Vitro Diagnostics markets, is proud to announce the achievement of the internationally recognized quality standard EN ISO 13485:2016 and MDSAP certification for our Quality Management System, demonstrating our commitment to the quality of our IVD products. The Re-certification audit was completed over the course of three days, under the full supervision of three professional auditors from TÜV SÜD.
Our process controls, documentation, and quality standards exceed all ISO 13485 and MDSAP requirements. By this, our customers can expect a constant and high level of reliability and transparency from our work. The quality of our products and services is supported by every employee.
The Quality Management System is, according to MDSAP, additionally based on the requirements of US Quality Systems Regulations (21 CFR 820), Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), Japanese QMS Ordinance (MHLW MO 169) and the Canadian Medical Device Regulations SOR/98-282, as well as the applicable GMP requirements.
Certification is a proof of quality. It also provides an advantage for you, our customers. Because of certifications, you can easily distinguish between higher quality and lower quality suppliers of IVD products. ISO 13485 and MDSAP certification enables BÜHLMANN Laboratories AG to conduct business internationally in the highly-regulated sectors of the European Union, Canada, Brasil and other countries.
What is EN ISO 13485:2016
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
For more information on ISO 13485, visit the International Organization for Standardization’s website (www.iso.org).
What is Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system, focused on the Quality Management System (QMS) and regulatory requirements, that satisfies the requirements of multiple regulatory jurisdictions participating in the program.
International Regulatory that are participating in the MDSAP include:
Therapeutic Goods Administration of Australia
Brazil’s Agência Nacional de Vigilância Sanitária
Health Canada
Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
U.S. Food and Drug Administration
For more information on MDSAP, visit the MDSAP website (https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap).