Regulatory Services for Medical Software

What we do:

We help clients develop a regulatory strategy for entering or staying in the EU and US markets. We guide them through the entire submission process, compile 510(k) and/or technical documentation, and assist with application submission. During the approval process, we support communication and responses to questions from the notified body or FDA, ensuring a smooth and efficient regulatory journey.

Customer benefits:

With our help, clients stay compliant with all applicable regulatory requirements with minimal effort, allowing them to focus on product development, gaining new customers, and achieving faster market entry.