Maybe you’ve head or “technical debt”? 🧑💻 😈 ☹️
But, have you heard of “regulatory debt”? 📑 📜 😈 😰
Technical debt happens when a development team rushes a product, cutting corners and knowing they'll have to fix those later.
Regulatory debt is similar. Teams that take shortcuts in setting up their quality systems or software development processes, like EN 62304, create future issues. These can block FDA or CE certifications later on.
Like technical debt, regulatory debt should be avoided. And it doesn't have to be a big hassle if you approach it the right way.
Startups need to understand what the FDA and European agencies require. Important things to know include:
🔸 When and what QMS needs to be implemented
🔸 Classification of technology for different markets
🔸 Planning timeframes for products accordingly
🔸 Estimating price of market approvals, planning use of funds
🔸 When and how to contact regulatory authorities
Both the FDA and the EU stress the need for traceability and transparency. Get these in place early to avoid more problems—and more regulatory debt—down the line.
Start off with a strong foundation by developing a regulatory infrastructure:
🔸 Managed processes/SOPs
🔸 Risk management strategies
🔸 An organizational commitment to quality
🔸 Process quality
🔸 Corrective and preventive actions
Best practices should also include keeping detailed technical documentation, design specs, requirements traceability matrices, and validation records.
Startups can manage this internally. You don’t need to, and shouldn't, outsource this work. But it helps to have someone train your team so you can handle regulatory affairs on your own.
This is why Digital Health Works supports startups in setting up their regulatory teams, as its fundamental to later stage commercialization.