Monsenso successfully completes ISO 13485 re-certification audit

Monsenso successfully completes ISO 13485 re-certification audit

Copenhagen, Denmark 

Monsenso is proud to announce the successful completion of its ISO 13485 re-certification audit, reaffirming our commitment to the highest standards of quality and safety in the development of digital health solutions for mental health.

ISO 13485 is the internationally recognised gold standard for medical device companies, ensuring that products consistently meet customer requirements, regulatory expectations, and the highest levels of safety and efficacy. The re-certification confirms that Monsenso’s Quality Management System (QMS) continues to meet stringent requirements specific to the medical device industry.

“Ensuring quality and compliance is at the heart of what we do. Our ISO 13485 re-certification underscores our dedication to delivering safe, effective, and reliable solutions that healthcare providers and patients can trust,” says Thomas Lethenborg, CEO at Monsenso.

This achievement reflects Monsenso’s ongoing efforts to provide secure, clinically validated mobile health solutions that empower patients, support clinicians, and strengthen health services worldwide.

For additional information, please contact:

Nanna Iversen

Chief Operating Officer

iversen@monsenso.com

+45 27267120


To learn more or explore a pilot or integration, book a demo or get in touch via our website.

 

Monsenso completes ISO 27001 surveillance audit

Monsenso completes ISO 27001 surveillance audit

Copenhagen, Denmark 

Monsenso is pleased to announce the successful completion of its ISO 27001 surveillance audit, further validating our commitment to world-class information security.

ISO 27001 is the leading international standard for information security management systems (ISMS). It ensures that organisations implement comprehensive processes to protect sensitive information, intellectual property, and third-party data in accordance with globally recognised best practices.

The successful audit confirms that Monsenso maintains robust data protection standards, ensuring the confidentiality, integrity, and availability of sensitive health data collected and processed through our platform.

“Data security is a cornerstone of trust in digital health. This audit reaffirms that Monsenso continues to protect user data at the highest level, giving patients, clinicians, and partners the confidence they need to embrace digital mental health solutions,” says Thomas Lethenborg, CEO at Monsenso.

By combining rigorous information security practices with high-quality, clinically validated digital solutions, Monsenso remains committed to supporting healthcare providers and researchers with technology that is not only innovative but also safe and trustworthy.

For additional information, please contact:

Nanna Iversen

Chief Operating Officer

iversen@monsenso.com

+45 27267120


To learn more or explore a pilot or integration, book a demo or get in touch via our website.