ERP Strategies to Navigate Compliance in MedTech

 Industry figures show it takes an average of 36 months to develop a medical device—though it could be as long as 114 months in the case of more complex ones. 

But that’s not the whole story. Clinical trials, depending on their scope, take months to conclude, while the FDA’s premarket approval application (PMA) can take up to 180 days to complete. Devices are also monitored in the field after they’ve been approved in case concerns about their safety and effectiveness arise. 

Last but not least, factors outside your control might delay the time it takes for your product to reach the market. Lay-offs at the FDA coincided with a drop in high-risk medical device approvals in 2025, making it difficult for manufacturers to realize their commercial goals. 

 All this means you need to have robust processes in place to give your product the best chance of approval and longevity in the market. 

Good Manufacturing Practices (GMP) must be followed and documented from the start. It’s a non-negotiable for approval needed and ensuring your product remains safe and effective throughout its lifecycle.