Aseptika Ltd Announces ISO 13485:2016 Quality Certification Achievement

Member News published by Aseptika (Activ8rlives), under Healthcare Applications, Innovation / Incubation, Internet of Things (IoT), Mobile Applications, Regulatory / Policy / Standards

Aseptika Ltd (, 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.

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