Excell Battery Announces ISO 13485 Certification
We’re pleased to announce that Excell Battery has received ISO 13485:2016 certification from SGS for the design and manufacture of battery packs for medical device applications. “We’re very excited to receive ISO 13485:2016 medical certification, which ensures that our full end-to-end value chain is performing at the highest standard from a safety quality perspective,” said Ian Kane, CEO of Excell Battery.
Receiving the ISO 13485:2016 certificate is a significant milestone for Excell Battery. The achievement further confirms the safety and reliability of Excell Battery’s medical battery system design and supply for medical devices and equipment.
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About ISO 13485
ISO 13485:2016 was written by the International Organization for Standardization to support medical device manufacturers to ensure that their Quality Management Systems (QMS) meet regulatory requirements.
There have been three editions of the standard ISO 13485 since 1996 with ISO 13485:2016 being the most current edition. ISO 13485 is an internationally-recognized quality standard for the medical device industry and is considered a requirement for many firms offering medical device products. The certification ensures companies manufacture products that are safe for human health by establishing effective QMS.
When creating a battery that supports medical devices, human health is the top priority. Safety, reliability, uniformity, timely delivery and traceability of components are critical requirements for any battery pack, and these requirements are emphasized in the ISO 13485 standard.
Having the certification allows organizations to deliver top-quality medical devices that consistently meet customer and regulatory requirements while demonstrating an understanding of the medical field.