Delivering quality: CE mark and ISO 13485 certificate

ISO-13485 CE certification startup

Delivering quality: CE mark and ISO 13485 certificate

Delivering quality: CE mark and ISO 13485 certificate 1150 767 Skinive
Artem Lian Head of DataScience

Artem Lian

CTO, Head of DataScience

“Considering that we develop software in the field of medicine, it is very important for us to build processes for the further development of the product in accordance with the regulatory requirements of the European Union and the United States. The QMS allows you to track all current regulatory documents through the Regulatory support process. “ – commented Artem Lyan, Skinive co-founder and CTO.

Kirill Atstarov CEO Skinive

Kirill Atstarov

CEO, Co-founder

“The implementation of ISO 13485: 2016 is a key milestone on our journey towards full compliance with global health regulations. We look forward to supporting the global community of dermatologists and skin health professionals with Skinive in Q4 2020.” – commented Kirill Atstarov, Skinive CEO and Co-founder.

The Skinive quality review was carried out by a team of experts from XportKat, an international consulting company, the QMS audit is planned by a certification body authority based in Czech Republic, Prague.

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* QMS (quality management system) is a set of processes within an organization aimed at identifying, measuring, controlling, and improving core activities in accordance with customer requirements and regulatory requirements applicable to your organization’s medical devices and related services. Most countries have also recognized international standards published by committees such as the International Organization for Standardization (ISO) as a core requirement for compliance.

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