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).