BÜHLMANN Laboratories AG is proud to announce the achievement of its first “EU Quality Management System Certificate (IVDR)” from TÜV SÜD Product Service, one of the notified bodies under the new In Vitro Diagnostic Medical Devices Regulation (IVDR), already in February 2022. The certification applies to more than 16 products of BÜHLMANNs product portfolio.
This “EU Quality Management System Certificate (IVDR)” is mandatory for any manufacturer of In Vitro Diagnostic Devices (IVDs) to issue declarations of conformity for their products and to have them (re-)certified in compliance with the new regulation.
BÜHLMANN Laboratories AG fully supports the new In Vitro Diagnostics Medical Devices Regulation (IVDR 2017/746) as it aims to ensure a smooth functioning of the EU market based on a high level of health protection for patients and users.
As BÜHLMANN offers several different product groups the completion of all IVDR certifications is still an ongoing process. BÜHLMANN Laboratories AG is actively managing this important transition to ensure its products are continuously available to healthcare professionals and patients without any interruptions.
IVDR (EU) 2017/746 CERTIFICATE
The In-Vitro Diagnostic Medical Devices Regulation (IVDR) will replace the existing In-Vitro Diagnostic Medical Devices Directive (IVDD).
For further information, please visit: EUR-Lex
EN ISO 13485:2016 and MDSAP certification
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.
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).
EN ISO 13485:2016 CERTIFICATE
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.
Our 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) and the Canadian Medical Device Regulations SOR/98-282, as well as the applicable GMP requirements.
BÜHLMANN works with its distribution partners to ensure compliance with regulations in countries not mentioned above, e.g.: Japan – Japanese QMS Ordinance (MHLW MO 169), Korea – Act on In Vitro Diagnostic Medical Devices from Korean MFDS and Taiwan – Taiwan’s Pharmaceutical Affairs Act.
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 and other countries worldwide.
International Regulatory that are participating in the MDSAP include:
Therapeutic Goods Administration of Australia
Brazil’s Agência Nacional de Vigilância Sanitária
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).