We’re honored to have maintained ISO 13485 certification for our R&D and manufacturing facilities since 2019, with TÜV Rheinland of Germany as our auditor.

We’re honored to have maintained ISO 13485 certification for our R&D and manufacturing facilities since 2019, with TÜV Rheinland of Germany as our auditor. This certification specifically covers our design and manufacturing of battery packs and chargers for medical devices.

Our ISO 13485 certification reflects our ongoing commitment to delivering safe and reliable power solutions for the healthcare industry. It validates our adherence to stringent quality and regulatory standards, as verified through regular, comprehensive audits by TÜV Rheinland.

ISO 13485 is relevant to your device FDA approvals as it serves as a harmonized quality management system standard that aligns with FDA regulations under 21 CFR Part 820, ensuring that medical device manufacturers meet both international and U.S. safety and quality requirements for their products.

Since receiving this certification, we’ve successfully delivered compliant medical battery solutions, supporting healthcare professionals and patients worldwide.We’re grateful for the trust our clients place in us, and we remain dedicated to maintaining the highest standards in our industry.

Let’s have a conversation about how we can meet your needs.