https://www.alexandertechnologies.com/wp-content/uploads/2020/08/news-placeholder-logo.jpg 350 900 Sam Aspden https://firstname.lastname@example.org Sam Aspden2019-01-26 09:41:482022-06-07 10:55:54Alexander Technologies Earns ISO 13485 Medical Device Quality Certification for Battery Packs and Chargers
Alexander Technologies Earns ISO 13485 Medical Device Quality Certification for Battery Packs and Chargers
Peterlee, UK, December 18th, 2018 — Alexander Technologies Europe Ltd, a leading European and North American designer and manufacturer of custom battery pack and charger solutions for medical device OEMs, has been awarded International Organization for Standardization (ISO) 13485:2016 certification for medical device quality management systems. Alexander Technologies manufactures custom designed OEM battery packs includes both Li-Ion and NiMH chemistries.
These packs are designed for portable power solutions for the most stringent of OEM applications. Applications include mission critical and lifesaving devices such as ventilators and defibrillators. These batteries also include custom designed BMS’s per the applications’ specifications that ensures safety, high performance, long life, and high value.
This ISO certification is another milestone for Alexander following the company’s recent ISO9001:2015 certification earlier in 2018. About Alexander Technologies Europe Ltd., ISO 13485 certification:
- ISO certification affirms to Alexanders Technologies OEM customers compliance for their medical device power source.
- To achieve certification, Alexander invested significant time and resources undergoing independent reviews of the company’s processes, documentation, and general culture of quality in accordance with ISO stringent guidelines.
- ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies based in Geneva, Switzerland.
- 13485:2016 is the latest update to the ISO criteria, previously revised in 2003.
This long-awaited revision expands risk management, adds new safeguards, and outlines new policies for quality control in supply chain management. Having the ISO 13485 quality system means that Alexander Technologies has validated it’s processes that enables Alexander Technologies to develop products at the speed required to safely bring battery pack innovation to their OEM medical device customers.
About Alexander Technologies Europe Ltd
As a leading European and North American designer and manufacturer of rechargeable batteries, chargers and battery maintenance equipment, Alexander Technologies uses cutting edge design and development in delivering innovative solutions and complete compatibility between the battery and charging system. With advanced design in Europe and the US and assembly plants in the UK and Malaysia, Alexander is recognized as a design leader in portable power. Our engineers’ partner with the OEM at the early stages of design in an effort to meet customer specification and provide value to the OEM, saving the customer time, money and valuable human resources. Our engineering department provides a single source for power design needs, utilizing our unique Systems Approach, that includes battery pack and charger design. The engineering professionals at Alexander Technologies seek to create the most cost-effective solutions for the application. This is great benefit to the OEM, allowing it to source the required power solutions from a single supplier. Alexander Technologies provides integrated power and charger solutions for Powered Air Purifying Respirators, Portable Medical Devices, Back Up Power Sources, Professional Power Tool, Robotics, and many other applications, plus Battery Charger/Conditioners manufactured and engineered to exceed industry standards in product quality and reliability.