06/12/2024
Certification transition
Certified by GMED
As of October 21st 2024
Between September 2022 and October 2024, DEKRA Certification GmbH certified the conformity of our Quality Management System (QMS) to ISO 13485 and our compliance with the requirements of the In Vitro Diagnostic Regulation (IVDR). As of October 21st of 2024, we transitioned to certification by GMED.
GMED is an accredited EU Notified Body, that specializes in certifications for both quality management systems and product conformity within the medical and diagnostic industries.
GMED is now the second Notified Body to confirm that our Quality Management System meets the rigorous requirements of ISO 13485 and the IVDR. This further validates our dedication to ensuring safety, quality, and reliability in our processes and products.
ISO 13485
For the control of processes of the Quality Management System (QMS)
ISO 13485:2016 is the internationally recognized standard for Quality Management Systems in the medical device sector. It focuses on process control, ensuring consistent quality across all operations related to design, manufacturing, and service.
IVDR
For Product Compliance
Under the IVDR, Notified Bodies like GMED assess not only the QMS but also the compliance of specific products with regulatory requirements. This ensures the safety, performance, and regulatory adherence of all devices entering the EU market.
Why GMED?
Our decision to transition to GMED reflects our commitment to advancing more rapidly in the implementation of full IVDR compliance and maintaining the highest standards of quality.
What Changes on the product labels and IFU’s?
- The Notified Body number changes to 0459 (you will see this reference on our kits instead of the DEKRA number 0124).
What Remains the Same?
- The scope of our certificate remains unchanged.
- The expiry date of our certificate remains unchanged.
- Historical Declarations of Conformity remain valid.
- Product registrations remain unaffected.
Our new GMED certificate is now available for download.
We thank you for your continued trust in our commitment to quality and compliance. Should you have any questions, please feel free to reach out.
