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

Young people are at higher risk of having an asthma attack than any other age group living with the condition, the charity Asthma UK is warning

Posted on January 23, 2019

Aseptika wins grant from Innovate UK to undertake a clinical trial with its child asthma solution

Posted on January 21, 2019

Activ8rlives⁴ Health+Wellbeing App by Aseptika achieves CE mark as a medical device

Posted on January 14, 2019

Weigh-ins and tips to help prevent piling on the pounds at Christmas

Posted on December 12, 2018

Pollution and Respiratory Disease combination causing a lot of health problems

Posted on December 10, 2018