Safety and quality are non-negotiable in the medical devices
industry. Regulatory requirements are becoming increasingly
stringent throughout every step of a product’s life cycle,
including service and delivery. More and more, organizations
are being put under a microscope, expected to demonstrate
their quality management processes and ensure best
practices in everything they do. 

At genae, we tap into our wide range of quality and regulatory experience and expertise to guide you through every stage of your clinical project.

Gain insight in how we support our customers through this must-read case study. For a wearable devices start-up, we were asked to establish and implement a Quality Management System (QMS) in accordance with ISO 13485, plus prepare a Technical File so the product could obtain a CE Mark.

Download this case study and discover our quality expertise.