What's Happening?
Practical Quality & Regulatory has joined forces with the Johner Institute and Svante Medical to create Elevate MedTech, a new alliance aimed at addressing the growing complexity of medical device regulations. This collaboration brings together a diverse
team with extensive experience in quality assurance and regulatory affairs, complemented by clinical insights. Elevate MedTech offers a comprehensive range of services, including regulatory consulting, quality assurance, clinical consulting, and international supplier auditing. The alliance aims to streamline the pathway from design to compliance and market access for medical devices, digital health, and biopharma products.
Why It's Important?
The formation of Elevate MedTech is significant as it addresses the increasing regulatory challenges faced by medical device companies. By providing a streamlined approach to compliance and market access, the alliance can help companies reduce time and costs associated with regulatory approval processes. This is particularly important for start-ups and SMEs looking to enter the market efficiently. The collaboration also highlights the importance of integrating clinical insights into regulatory strategies, ensuring that products meet both technical and customer needs.
