MDR Certification

We’re proud to announce that Adtec Healthcare Limited has officially received MDR certification for our innovative SteriPlas Cold Plasma medical device — a significant step forward in our mission to improve wound care outcomes through pioneering technology.

 

This certification under the European Medical Device Regulation (EU MDR) is more than just a regulatory achievement — it’s a testament to years of hard work, rigorous testing, and unwavering commitment to patient safety.

 

✅ New clinical evidence
✅ Post-market surveillance (PMS) data
✅ Enhanced quality management systems (QMS)
✅ Comprehensive biocompatibility and safety testing
✅ Hundreds of supporting technical documents
✅ Two years of detailed regulatory engagement

 

Every element of this process was driven by the dedication of both current and former colleagues whose expertise and passion helped bring the SteriPlas to where it is today. We extend our deepest thanks to our incredible team — this milestone belongs to you.

 

As we continue to expand our operations and form new distribution partnerships around the world, this certification positions us to scale with confidence and deliver even greater value to clinicians and patients globally.

 

The journey doesn't stop here. With the SteriPlas now MDR certified, we’re excited to explore new clinical applications, collaborative opportunities, and broader international reach.


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