Navigating the regulatory minefield of ISO 13485, ISO 14971 and FDA CFR 820 whilst developing a medical device is often the key delay in getting a product to market. Disparate documentation and product development data only ever contributes to these delays and can lead to missed revenue opportunities for medical device organisations.
Track, trace and accelerate your product development using the Opvia cloud platform. Opvia’s unique solution allows teams to connect design and quality control data by product, from requirements to inputs, outputs and associated risks. These design control data sets sit alongside the version controlled documentation needed to seek regulatory approval.
With everything under one roof, identifying problems or improvements and tracing back to their root causes becomes a rapid and seamless experience.