We align your regulatory path with the business case.  Because innovation, compliance and business go hand in hand. Reimbursement Pathway Regulatory Pathway Development and Manufacturing timelines Reimbursement: How will you get paid? Reimbursement strategy should drive device design—not follow it. If you don't fit into an existing code, expect a 5+ year battle to change the system. How are equivalent devices reimbursed in your target market? Does the current payment model actually support your business case? Early Regulatory Strategy The regulatory pathway highly depends on the type of medical device and clinical data. Define the device classification and registration pathway. Assess the need for costly clinical investigations (studies) These days, U.S. registration may be faster and more straightforward than Europe. How solid is your Proof of Concept (POC)? Gather as much direct feedback from doctors and patients as possible. Ensure it withstands critical performance tests Development and Manufacturing timelines/cost The timelines are a function of product complexity and regulatory pathway. As the project may be subject to change, this step will be updated.

In a workshop, we define the applicable standards and regulations for your innovation. Don't lose time for digitalization - Pull them from our dataset.

STEP 3: Development Procedures (Modular QMS) Focus on processes, that reduce patient risk. This is called a risked-based approach. Follow these procedures, to set the right focus. - Pick from 50+ predefined digital processes.  - All processes are already linked to global requirements.  - Stop building a paper library; start using a digital QMS.

STEP 4: Product Documentation: Design Input: (target: ≤ 3 months) A mechatronic medical device must comply with ~30,000 regulatory requirements. 👉 Use applicable product standards for safety and performance wherever you can Then, risk reduction is already in place. Proper Design Input (target: ≤ 3 months) Define user needs (MAX 5), intended use, and conduct first clinical research. Identify the top 10 product risks (doctors can tell you most immediately). Write up to 40 key product requirements — stay focused! 👉 Skip this, and you’ll likely face a costly redesign later. STEP 4: Design & Development (6–24 months) Design - Prototype - Test - Repeat Use Materials that are cleanable, biocompatible and can be sterile processed. Use automated testing and validated environments for software. 👉 Involve users in testing early — it's called usability engineering! STEP 4: Plan Testing Strategy & Design Transfer (1–3 years) Reproducible setups, justified acceptance criteria, statistical evaluations. Remember: the best quality comes from good science. Plan strategically: this phase can be resource-intensive. Secure sterile packaging solutions early. STEP 4: Design Verification and Validation Ensure patient safety through rigorous, representative testing. Account for costly steps like human factors studies and clinical investigations.

ColabON's digital approach comes with Report logic for CE and 510k. No more copy-paste. Just hit the report bottom. The Phase until market approval can be anywhere between 0 month to 2 years and more. 0 month if you can self-declare your CE Mark 90 days if your 510k goes through without questions Years if you need to collect a lot of clinical data