1. Take a collaborative approach to project management

Every successful medical device begins with a solid idea. A clear definition of the intended use is critical for determining the correct requirements. But it’s the teamwork and structure behind that idea that ultimately determine its success. 

As soon as possible, it’s a good idea to set up a cross-functional team consisting of design, clinical, marketing, and risk management specialists. These stakeholders can help define both the benefits and risks associated with the device and shape its initial scope. 

A strong project management plan ensures all stakeholders are aligned and that no critical step is overlooked. We recommend a three-phase approach to project management:

• Phase 1 – Planning and feasibility: Define needs, assess feasibility, and ensure the right expertise is in place.
• Phase 2 – Execution: Develop, prototype, test, and iterate the product, ensuring that all technical and customer requirements are captured.
• Phase 3 – Market readiness and scale-up: Document evidence, validate compliance, and prepare for large-scale manufacturing and regulatory submission.

2. Involve an expert in regulatory compliance

Many companies only realize the need for external regulatory expertise at the testing phase. It’s common for our regulatory consultants to get involved just after a company has obtained the test results from a working product. We often get the call because companies have become overwhelmed by the complexities of assembling a compliant technical file. 

There’s a good reason for this: compliance extends beyond the device itself. Everything from user manuals and labels to packaging and instructions for use form part of the regulated product package. Often, we find gaps in the documentation, or regulatory requirements have not been fully integrated into the product specifications. 

At this point, a regulatory consultant can help ensure the product, labeling, and accompanying information all comply with applicable standards, whether that’s the EU Medical Device Regulation (MDR) or the FDA’s Code of Federal Regulations (CFR).

3. Integrate regulatory requirements early on

Taking account of the regulations at the very start saves time, money, and frustration. As a rough measure, the higher the risk class of the device, the earlier regulatory and quality experts should be involved.

Companies that delay this step may find they’ve conducted testing or generated data that fails to meet regulatory standards, requiring costly rework or new trials. By contrast, early integration ensures design and documentation are fully aligned with state-of-the-art standards for the device type and target market.

The message here is simple: skipping steps in the hope of speeding up the process usually backfires, causing the opposite effect, adding costs and creating delays later down the line.

4. Connect with the right clinical data and experts

Benchmarking clinical performance is a cornerstone of defining medical device requirements, but sourcing the right data isn’t always easy. It’s important to include clinical expertise within the project team from the start.

Clinical experts can access relevant literature, liaise with hospitals, and connect with key opinion leaders. If public data or existing literature aren’t sufficient, companies will likely need to run their own clinical investigations to generate risk-benefit evidence.

This process is resource-intensive, so early assessment of data needs is critical. Determining whether clinical trials are necessary, and planning them appropriately, can significantly impact the time it takes to reach the market.

5. Select the right Notified Body

Selecting the right Notified Body is a strategic decision, not a procedural one. Dawn Technology’s consultants can help clients identify bodies with the right expertise for their product category. Key factors include:

• Experience with the specific device type
• Language compatibility for reviewing documentation
• Availability and responsiveness
• Alignment of company size 

It’s important to emphasize that a good match between manufacturer and Notified Body streamlines communication and ensures smoother assessment throughout the process.

6. Optimize engagement with regulatory experts

The most effective regulatory collaborations begin early. Engaging consultants at the concept stage ensures that design and documentation follow best practices from the outset.

If experts are only brought in once testing or data collection has already started, companies risk finding that their evidence does not meet regulatory expectations. Equally, if a quality management system does not support proper documentation or change management, it can leave significant gaps in the technical file.

Early involvement prevents these issues before they arise and ensures compliance is built into the product’s DNA.

7. Launch with a limited scope, then extend it

Product development always involves balancing innovation, speed, and compliance. One of the most common challenges is managing expectations between marketing and regulatory teams.

In many cases, it’s more effective to launch with a limited scope, a first version with a clearly defined intended use, rather than attempting to cover every possible application from the outset. This focused approach helps achieve faster approval and enables future expansion once real-world data are available.

After launch, additional evidence from market use and physician-led studies can support extending indications or expanding user populations. Once on the market, companies are already embedded in the clinical environment, making it easier to generate meaningful new data for further claims.

Action‑oriented takeaways

Getting the requirements right isn’t optional; it’s the gatekeeper to a viable, compliant product. Below is a no‑fluff checklist you can start using today, followed by a quick note on how Dawn Technology can plug the gaps you still see.

1. Lock the requirements in at the outset
   Regulatory and clinical inputs belong in the project charter, not as an after‑thought. Map the applicable MDR clauses or FDA CFR sections to each functional requirement before any design work begins.
2. Staff the team with the right specialists
   A single ‘QA’ person won’t cut it. Assemble a dedicated trio, regulatory affairs, clinical affairs, and quality systems, and give them authority to veto any requirement that lacks compliance evidence.
3. Treat the product as a living document
   Requirements evolve with new data, post‑market feedback, and regulatory updates. Implement a formal change‑control log that captures who approved each amendment and why.
4. Start narrow, get approved fast
   Define a tight intended use and a limited claim set for the first market entry. The narrower the scope, the fewer the pre‑market hurdles and the quicker you can ship.
5. Scale only after you have real‑world evidence
   Once the device is on the market, harvest usage data, adverse‑event reports, and clinician feedback. Use that hard evidence to justify expanded indications or additional markets in a controlled, compliant manner.

Need a hand turning this checklist into a working process?

Dawn Technology’s regulatory consultants specialize in translating MDR/FDA mandates into actionable requirement sets. We can:

• Conduct a gap analysis against your current requirement matrix.
• Draft a regulatory‑aligned requirement specification that satisfies both EU and U.S. pathways.
• Set up the change‑control framework you need to keep the document alive through the product lifecycle.

Reach out, and we’ll map the exact steps you need to move from ‘draft’ to ‘approved’.

Contact us today to accelerate your path to market with clarity, compliance, and confidence.