Activ8rlives News

 

Aseptika Ltd Announces ISO 13485:2016 Quality Certification Achievement

Posted on December 3, 2018

Aseptika Ltd (www.activ8rlives.com), the connected healthcare company, is pleased to announce that it has achieved certification to ISO 13485:2016 under Certificate Number MD691414 with BSI as its Notified Body.

This is a major milestone in the development of Aseptika as its certification covers the development and certification (CE-marking) of its own medical devices, medically-certified Apps and UK-based Cloud data management system.

Dr Elena Traistaru, Quality and Information Governance Manager commented:

“With certification to ISO 13485:2016, Aseptika has CE-marked a series of our own medical devices and Apps, including the new Asthma+me solution for children and young people with moderate-to-severe Asthma and the PUFFClicker smart inhaler tracker. It is a significant investment for us as a company to achieve this quality standard and will be the foundation for the manufacture of our present and future medical devices, and our growing number of solutions which support patients with long-term conditions to self-care and keep in good health.”

Aseptika Limited has been certified by BSI to ISO 13485:2016 under certificate number MD691414.

Aseptika Limited has been certified by BSI to ISO 13485:2016 under certificate number MD691414.

 

Tags: , , , , ,

Share:

Latest Posts

Free-For-Life Healthcare Self-Management Activ8rlives4 Health+Wellness App Update

Posted on August 11, 2021

Stigma: an unmet public health priority in COPD

Posted on June 30, 2021

Latest guidance from GPs about using pulse oximetry to help if you catch COVID-19

Posted on January 12, 2021

The changing face of cardiac rehab: How health technology has improved the way cardiac patients access vital rehabilitation services

Posted on November 16, 2020

Taking Cardiac Rehab Online during Lockdown

Posted on September 14, 2020