05 Sep 2025

biodrook has received DSTU EN ISO 13485:2018 certification

A new stage of responsibility and trust in the production of medical devices

We are pleased to announce that the company biodrook has successfully passed certification for compliance with the international standard DSTU EN ISO 13485:2018 — one of the highest industry standards in the field of development and production of medical devices.

What is ISO 13485 and why is it important?

ISO 13485 is an international quality management standard specifically created for medical devices. It regulates all stages of the product life cycle: from design, development, and production — to post-market monitoring, traceability, and user feedback.

Obtaining this certificate means that biodrook’s production processes comply with international safety and quality requirements, and all products undergo proven quality control and risk management procedures. At biodrook, a transparent system of documentation, change tracking, and accountability has been established.

Why is this important for doctors, partners, clinics, and patients?

This certification is not just a formality. It is a guarantee of trust:

For clinics and doctors — confidence in the quality of implants and related solutions
For international partners — compliance with global requirements, simplification of import procedures and joint projects
For investors — confirmation of the maturity of internal processes and readiness for scaling
For the state — an example of implementing a new generation of quality medical infrastructure

Our approach is not formal, but systemic.
We did not just “receive a certificate”. We have implemented a culture of quality that covers every step — from the first sketch to the sterile packaging of the finished product. The focus is on the patient, their safety, comfort, and quality of life.

This achievement became possible thanks to the biodrook team — engineers, technologists, quality specialists, and administrative staff. Their dedication, precision, and strategic vision shape the future of the Ukrainian medtech industry every day.

We also sincerely thank our partners, advisors, and the certification body for their support and professional guidance.

What’s next?
This is only one of the steps. Ahead — product certification, entry into the Ukrainian market, new products and markets, and new challenges. But the foundation has already been laid. And we are ready to move forward.

biodrook — developing the medicine of the future. In Ukraine. For the world.

Learn more about the technology and application of custom implants at biodrook.com
Contact the team: moc.koordoib%40ofni