Quality Policy and Standards
As a technology leader in mobile health (mHealth) solutions for mental health, Monsenso is ISO 13485 certified. ISO 13485 is the gold standard for medical device companies to ensure the quality, safety and efficacy of products in the medical device field. This certification ensures that the product in question, consistently meets customer requirements and regulatory requirements applicable to medical devices and other related services.
“Monsenso adheres to the highest security standards. Beyond, being ISO 13485, Monsenso holds the ISO 27001 certifications, a TGA certification and class 1 CE mark.” says Thomas Lethenborg, CEO at Monsenso.
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Copenhagen, Denmark – 16 August 2016. Monsenso, today announced that its mHealth solution received a Class I medical-device certification, from the Australian Register of Therapeutic Goods Administration (TGA).
The mHealth solution received the TGA certification in cooperation with Emergo, a consultancy company specialising in regulatory compliance for medical devices, with funding from the Danish Market Development Fund.
Thomas Lethenborg, CEO at Monsenso, commented “We are very satisfied that the Monsenso mHealth solution received the TGA certification and is now ready to be launched in the Australian market. Although we already have a customer in Australia, this certification provides us with the means to commercialise the solution nation-wide.”
This certification guarantees that a manufacturer’s product meets the essential requirements stipulated by the Australian Register of Terapeutic Administration.
“Holding the right certifications, and offering a high level of data security is essential for healthcare providers in all markets –including Australia. Therefore, it is important that Monsenso possesses the necessary quality control standards and adequate security measures to succeed world-wide” added Mr. Lethenborg.
The next steps for Monsenso are to obtain the ISO 13485 Certification; the ISO 27001 Data Security Certification; and to become HIPAA and FDA compliant. These certifications will be also obtained with the monetary support granted by the Danish Market Development Fund. You can download this article as PDF in English and Danish.