OUR STANDARDS
The basis for regulatory reliability
Quality is practiced and proven in every company in the Group. Our companies are certified in accordance with the relevant international standards, depending on their field of activity: ISO 13485 and ISO 9001 for quality management in medical technology, MDSAP as single audit evidence for the US, Canadian, Australian, Japanese and Brazilian markets, ISO 14971 for risk management and ISO 27001 and TISAX for information security. IEC 62304 and IEC 82304 apply to software development and verification, supplemented by IEC 62366 for usability and IEC 81001-5-1 as well as AAMI TR57 for cybersecurity risk management in a regulated environment. The EU Quality Management System Certificate in accordance with MDR and validation in accordance with GAMP5 round off the certification portfolio. FDA and CSA certifications for hardware development and production are also available.
ISO 9001
ISO 9001 is the international standard for quality management systems and forms the basis for structured, traceable processes in all areas of the company. The certification proves that we not only promise quality, but also systematically ensure and continuously improve it.
ISO 13485
ISO 13485 is the industry-specific quality management standard for medical devices and IVDs. Certification in accordance with the current 2016 edition is a prerequisite for the development, manufacture and distribution of medical devices in regulated markets worldwide and forms the basis for MDR and IVDR-compliant processes.
EU Quality Management System Certificate (MDR)
The EU QMS Certificate according to MDR confirms that our quality management system meets the requirements of the EU Medical Device Regulation (EU) 2017/745. It is a prerequisite for the CE marking of Class I medical devices with a measuring function, Is, Im and Class IIa upwards and is issued by a notified body.
DIN EN ISO/IEC 27001
ISO 27001 is the international standard for ISMS. The current certification according to the 2024 edition proves that we systematically manage information security, identify risks and guarantee the protection of sensitive data on a permanent basis. For our customers from regulated industries, this is not an additional service, but a prerequisite.
TISAX
TISAX (Trusted Information Security Assessment Exchange) is a recognized standard for information security based on the requirements of the VDA ISA catalog. Originally developed for the automotive industry, it has also established itself as proof of the secure handling of confidential information for IT service providers. For BAYOOSOFT, the TISAX certification proves that sensitive customer data and business information is protected according to demonstrably high security standards.
