TRUE SOURCE Achieves EU MDR 2017/745 Certification
After intensive work by the entire team at TRUE SOURCE Technology Co., Ltd., we are proud to announce that we have obtained the EU MDR 2017/745 Certificate, marking a major milestone in our commitment to international quality and safety standards for anti-decubitus air mattresses.
What This Certification Means
The Medical Device Regulation (MDR) 2017/745 is the European Union’s updated regulatory framework for medical devices, replacing the previous Medical Device Directive (MDD) with stricter requirements for clinical evidence, post-market surveillance, and traceability. Achieving MDR certification confirms that TRUE SOURCE’s anti-decubitus air mattresses meet rigorous EU standards for safety, performance, and quality management, allowing our products to be legally marketed and sold across all EU member states. For our distributors and healthcare partners, this certification provides an added layer of assurance that every product bearing the TRUE SOURCE name has been independently verified against some of the strictest medical device standards in the world.
A Milestone Built on 15 Years of Experience
TRUE SOURCE has been deeply involved in Taiwan’s medical device industry since 2009, with over 15 years of R&D and manufacturing expertise in anti-decubitus air mattresses. This new EU MDR certification builds on our existing Taiwan TFDA license and our completed SRN registration in EUDAMED, further strengthening our credentials as a trusted, internationally certified medical device manufacturer built on the strength of Made in Taiwan manufacturing.
What the Certification Process Involved
Achieving EU MDR 2017/745 certification required intensive, sustained effort across the entire organization, including comprehensive technical documentation, clinical evaluation, risk management review, and a thorough audit of our quality management system. Every TRUE SOURCE product line underwent detailed assessment to confirm compliance with the regulation’s enhanced requirements for safety, performance, and post-market monitoring. The process also involved close coordination between our R&D, regulatory affairs, and manufacturing teams to ensure that every anti-decubitus air mattress model, from our alternating pressure systems to our honeycomb gel cushions, met the regulation’s exacting standards from design through to production.
Why This Matters for Our Partners
- Confirms compliance with the EU’s most current, stringent medical device safety standards
- Enables continued and expanded distribution of TRUE SOURCE products across the European market
- Reinforces our long-standing commitment to quality, safety, and continuous product improvement
- Adds to our existing certifications, including Taiwan TFDA and EUDAMED SRN registration
- Gives distributors and healthcare institutions added confidence when recommending TRUE SOURCE solutions to patients and caregivers
Our Commitment to Quality Continues
Comfort and safety remain at the core of TRUE SOURCE’s product philosophy. The interaction between alternating air tube strips, including sound stability and comfort consistency, may appear simple, but it is actually a complex engineering challenge that requires extensive hands-on trials, long-term verification testing, and close coordination across hardware, mechanisms, software, and production. This EU MDR certification reflects that same rigorous standard, applied at the regulatory level.
Looking Ahead
TRUE SOURCE will continue to invest in R&D and quality assurance as we expand our international presence, including our upcoming Smart AUTO automatic-setting series, Smart AUTO Turn repositioning models, and LCD screen control options. With EU MDR certification now in place, we are better positioned than ever to serve hospitals, nursing homes, and home-care providers across Europe and beyond, while continuing to explore opportunities in new international markets.
Thank You to Our Team and Partners
This achievement would not have been possible without the dedication of our entire TRUE SOURCE team, as well as the trust of our distributors, healthcare partners, and customers around the world. From our R&D engineers to our regulatory affairs specialists and production staff, every department played a part in reaching this milestone. We look forward to continuing to deliver safe, certified, and innovative pressure-relief solutions as we move forward together.
Learn more about TRUE SOURCE and our full range of certified anti-decubitus air mattress solutions at our official website: www.medical-truesource.com/tw.
EU MDR 2017/745 Regulation（官方全文）：https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745