ISO 13485 certification: verifiable proof that BIRR works according to the MDR

What does it mean to have ISO 13485?

With the ISO 13485 certification, BIRR shows that we comply with the laws and regulations and that we work according to the MDR. Compliance with this standard is a requirement for most countries to market medical devices.

What is a quality management system?

A good quality management system is a structured approach with which we at BIRR organize and control our processes and activities in such a way that we can consistently deliver high-quality products. The emphasis is on the documentation and traceability of all processes, from design to delivery and service.

What does the ISO 13485 standard entail?

The purpose of the ISO 13485 standard is to ensure the safety of medical devices and to minimize risks to the patient. The standard sets requirements for the quality management system of BIRR and the way we deal with e.g. design, development and production of IVF Labware.

There are several important advantages associa- ted with this, such as:

Risk Management: ISO 13485 requires the implementation of a risk management process to identify and minimize potential risks during the production of our medical devices.

Continuous improvement: ISO 13485 encourages continuous improvement of our processes and management of the quality and safety of BIRR’s IVF Labware.

“I am proud to confirm that we are ISO 13485 under MDR certified, ensuring our IVF labware products meet the highest standards of quality and safety – critical for the success of every IVF treatment.”

Tom Vermeiden CEO BIRR

What is a quality management system?

A good quality management system is a structured approach with which we at BIRR organize and control our processes and activities in such a way that we can consistently deliver high-quality products. The emphasis is on the documentation and traceability of all processes, from design to delivery and service.

Does a company need both ISO 13485 and a CE mark to be able to market IVF Labware?

ISO 13485 and the CE marking complement each other, but they are not the same!

The CE marking indicates that the medical • device complies with the MDR.

The ISO 13485 certification proves that a company meets the requirements regarding the way in which an organization has organi- zed the design, development, production and maintenance of IVF Labware.

ISO 13485 helps to meet the legal requirements needed for CE marking. However, be aware that a manufacturer can be ISO 13485 certified without their products being CE marked. For the sale of medical devices, CE marking is mandatory under the MDR in many countries.

Download of Quality Certificates and Technical related documentation: For distributors and customers who need Certificates, QMS, DoC, CoC, Lot related CoA, IFU available to be downloaded in our quality portal. Please click on Quality Portal. You will have to fill in a password (if not available, please contact email).

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