Safety, Quality & Results You Can Trust
Eclipse is committed to providing superior, leading-edge technologies for practices and patients. Our company's products are held to the highest standards for quality, safety, reliability and results.
As of March 30th, 2020 Eclipse achieved Medical Device Single Auditor Program (MDSAP) certification, which is based on ISO 13485:2016 and satisfies the requirements of US FDA, Health Canada, Brazil (ANVISA), Japan (MHLW and PMDA) and Australia (Therapeutic Goods Administration). MDSAP certification is mandatory in Canada and other countries are expected to follow.
Eclipse is extremely proud to have achieved this certification and looks forward to continuing to provide superior products to its customers in the US and abroad.
Eclipse Founder and CEO Tom O'Brien wants to thank the quality department for putting in the hard work to make this certification possible. “This certification continues to validate that Eclipse is at the pinnacle of industry standards and regulation,” O'Brien says.
Our Quality Policy
Eclipse is committed to exceeding customer expectations through continuous evolution of safe and effective products. Our commitment is achieved by maintaining the effectiveness of the quality management system, periodic review of our objectives and compliance with all applicable regulatory and statutory requirements.
- ISO 13485:2016 and Canada – Medical Device Regulations – Part 1 – SOR 98/282; USA –21 CFR 820, 21, CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D.
Click the bsi logo below to view our MDSAP Certificate: