Certified Excellence

Committed to Global Quality Standards and Regulatory Compliance.

Our Quality Promise

At MEDSTEIN, quality is not just a department; it is a mindset embedded in every step of our manufacturing process. We understand that in the medical sector, compliance with international standards is the guarantee of patient safety and product reliability.

We proudly operate under a rigorous Quality Management System that meets the highest global benchmarks. Our products are designed, manufactured, and tested in strict accordance with European and International regulations, ensuring they are safe for use in hospitals, clinics, and medical facilities worldwide.

Our Compliance Portfolio

Although we hold the following accreditations, we treat our detailed technical files with confidentiality to protect our proprietary engineering data.

1. ISO 13485:2016 – Medical Devices Quality Management The gold standard for the medical industry. This certification verifies that MEDSTEIN’s comprehensive quality system specifically meets the regulatory requirements for medical device manufacturing.

2. CE Marking (European Conformity) Our products bear the CE mark, declaring conformity with the relevant EU Medical Device Regulations (MDR). This confirms that our products meet the essential health, safety, and environmental protection requirements for the European market.

3. ISO 9001:2015 – Quality Management System Demonstrating our ability to consistently provide products and services that meet customer and regulatory requirements.

4. ISO 14001:2015 – Environmental Management System Proof of our commitment to sustainable manufacturing and minimizing our environmental footprint.

5. ISO 45001:2018 – Occupational Health and Safety Ensuring a safe and healthy workplace for our employees, which translates to safer production processes.

Document Access & Verification

To prevent unauthorized use and to maintain the integrity of our regulatory documentation, full copies of our certificates, declaration of conformity documents, and test reports are available upon request.

We are happy to share these documents with our authorized distributors, hospital procurement departments, and regulatory bodies.

How to Request Documents: Please send an official request via email to our Regulatory Affairs Department. Kindly include your company details and the specific purpose of your request.

📧 E-mail: quality@medstein.com Subject Line: Request for Certification Documents

Our team typically responds to validation requests within 24 hours.