NOVO is ISO 13485 Certified for Medical Devices Development

We understand your quality requirements, and we are experts in developing customized solutions.

ISO 13485

Team up with NOVO to certify your medical project.

To better serve customers developing medical devices, Novo will now leverage an ISO 13485:2016 certified quality management system throughout the medical product development process.

Recognized internationally, the ISO 13485:2016 standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

IoT & Connected Devices - Oncology - Respiratory - Cardiovascular - Ophthalmology - Consumer Health
Implementing the ISO 13485:2016 requirements and having our quality management system certified was a natural evolution for our company. As we collaborate on more complex medical device development projects, we wanted our clients to be fully confident that our work complies with the high expectations of the FDA and the other health organizations.

Alexis Bilodeau
CEO & Cofounder

Our product strategy, design, and engineering teams will help you create compliant, market-ready medical devices.

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