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

'Aggressive' blood pressure control helps beat dementia, study finds

Posted on August 15, 2019

Asthma+me – the App being trialled to help children manage severe asthma

Posted on August 12, 2019

Asthma+me innovative technology-enabled solution for paediatric asthma is shortlisted for Best Technological Innovation: Digital

Posted on August 9, 2019

Aseptika wins big at West Midlands healthcare innovation awards

Posted on August 5, 2019

Novel medical-grade wearable patent granted to Aseptika for BuddyWOTCH

Posted on July 24, 2019