Nadia Ragnvald Caspersen
Senior consultant, QA/RA – GBA Key2Compliance
“We choose to go to the moon… not because it is easy, but because it is hard.” (John F. Kennedy)
– Honestly, he could’ve been talking about bringing a medical device to market.
It’s hard. It’s expensive. It’s regulated to the moon and back. But it’s also one of the most rewarding things you can do—if you know what you’re doing (or at least know who to ask).
In this article, I’ll be sharing the 6 key phases that every MedTech startup needs to navigate. Think of it as a roadmap for turning your brilliant idea into a compliant, fundable, launch-ready product—with fewer surprises and more investor nods.
Whether you’re building your first prototype or pitching your Series A, this article is for you.
Phase 1: Regulatory & Business Strategy
– Mission Planning Complete. Standing by for systems check.
So, you’ve got a brilliant idea for a medical device? That’s fantastic! But before you start sketching prototypes or dreaming of changing the world (or at least getting your first clinical study underway), let’s talk about the very first (and arguably most important) phase: aligning your regulatory pathway with your business strategy.
This isn’t just paperwork—it’s your launchpad. And yes, it’s where many startups either set themselves up for success… or for a very expensive detour.
What’s the Goal?
To build a solid foundation by ensuring your product is viable, compliant, and fundable. Think of it as your MedTech GPS: if you don’t know where you’re going, how will you convince investors to come along for the ride?
Key Activities:
- Define the Business Objective
What problem are you solving? Who cares about it? And why should they pay for it? - Market & Reimbursement Strategy
EU? US? UK? Mars? (Okay, maybe not Mars—yet.)
Understand where your product fits and how it gets paid for. - Product Qualification
Is it even a medical device? (Spoiler: not everything with a battery and a heartbeat monitor is.) - Device Classification & Regulatory Pathway
Class I, IIa, IIb, III, A, B, C, D—these classifications aren’t just labels; they define the regulatory expectations for your product. Whether you’re developing a medical device or an IVD, your classification determines the level of scrutiny, the documentation required, and whether a Notified Body needs to be involved.
Pro tip: Getting this right early on is critical. It shapes your development timeline, budget, and even your investor pitch. It’s not just a regulatory step—it’s a strategic cornerstone. - Competitor & Regulatory Landscape Analysis
What are others doing? And how can you do it smarter? - Regulatory Readiness Checklist
Intended use, patient population, use environment—yes, it’s a checklist, but it’s also your risk radar. Use it to ensure all internal, external, and product-specific factors are considered before moving forward. - Leadership & Funding Alignment
A clear regulatory roadmap = a compelling pitch deck. Investors love clarity.
Milestones:
- Business case and market prioritization approved
- Regulatory Strategy documented
- Device classification confirmed
- Initial funding secured
- Regulatory checklist completed and signed off
Why This Matters for Startups:
Many startups underestimate the true cost of bringing a device to market. When you hear the full number up front, it can feel like someone just dropped a defibrillator on your budget. But when you break it down—phase by phase—it becomes manageable, strategic, and even… exciting?
And remember: all that documentation? It’s not just red tape. It’s value. It’s IP. It’s what turns your napkin sketch into a fundable, scalable business.
Phase 2: Regulatory Planning & Market Intelligence
– All Systems Go for Launch Configuration.
You’ve got your regulatory strategy in place—great start! Now it’s time to roll up your sleeves and turn that strategy into a concrete, actionable plan. This phase is all about planning smart and knowing your markets so you can avoid surprises later (the bad kind, not the birthday cake kind).
What’s the Goal?
Translate your high-level regulatory strategy into a detailed plan and gather the intelligence you need to navigate your target markets with confidence.
Key Activities:
- Develop the Regulatory Plan
Use the output from Phase 1 to build a structured plan that includes:- Device description and intended purpose
- Risk classification and justification
- Applicable legal requirements and standards
- Conformity assessment route
- Roles, responsibilities, and required competencies
- Timeline and cost estimates
Pro tip: Don’t stop at the medical regulations. Have you looked one layer deeper? Your product might also fall under rules related to materials, electronics, environmental impact, or other sector-specific legislation. Identifying these early can save you from costly surprises later.
- Select Notified Body (if applicable)
- Is a Notified Body required based on your classification?
- Are they designated and authorized for the relevant regulatory frameworks (e.g., MDR, IVDR, or other applicable legislation)?
- Are they accepting new clients—and do they have time for you?
- Market-Specific Regulatory Intelligence
Prioritize countries based on your business strategy and regulatory complexity. For each market, identify:- Local regulatory authorities (e.g., MHRA, Swissmedic)
- Registration processes and timelines
- Language and translation requirements
- Mutual recognition or reliance on other approvals (e.g., FDA, CE)
- Identify Economic Operators
Define and document roles for:- Manufacturer
- Authorized Representative (AR)
- Importer
- Distributor
Pro tip: Make sure contracts and communication channels are in place.
- Resource Planning
Estimate the internal and external resources you’ll need:- Regulatory consultants
- Clinical experts
- Technical writers
Pro tip: Confirm availability and qualifications early—it saves headaches later.
- Regulatory Readiness Checklist
Ensure your Regulatory Plan is documented, version-controlled, and integrated into your QMS. Plan for regular updates and reviews—it’s a living document, not a one-time task.
Milestones:
- Regulatory Plan finalized and approved
- Notified Body engagement confirmed (if applicable)
- Market-specific regulatory requirements documented
- Economic operators identified and agreements initiated
- Resource plan and budget approved
Why This Matters for Startups
This is where your strategy becomes reality. Without a clear plan, even the best ideas can stall. And while it might feel like a lot of admin, this phase is what gives your project structure, direction, and credibility—especially when talking to investors or partners.
Phase 3:Product Development & QMS Implementation
– Fueling Complete. Final Systems Integration Underway.
Now that your regulatory plan is in place, it’s time to bring your product to life—on paper, in the lab, and in your quality system. This phase is where design meets discipline: you’re not just developing a device, you’re building the systems that will support it all the way to market (and beyond).
What’s the Goal?
Design and develop your medical device while implementing a compliant Quality Management System (QMS) that supports both regulatory and product requirements.
Key Activities:
- Finalize Design Inputs
Translate user needs and regulatory requirements into clear, testable design inputs:
- Functional, performance, and safety requirements
- Aligned with intended use and risk classification
- Risk Management
Develop a risk management plan (hello, ISO 14971!) and keep it alive throughout development:
- Identify hazards
- Evaluate and control risks
- Maintain a risk management file
- Prototype Development & Verification
Time to get hands-on:
- Build and test prototypes
- Conduct bench testing, usability studies, and simulations
- Document everything—if it’s not written down, it didn’t happen
- QMS Implementation (ISO 13485)
Set up a QMS that fits your product and your team:
- SOPs for design, document control, supplier management, complaints and CAPA
- Assign a Person Responsible for Regulatory Compliance (PRRC) if required (e.g., under EU MDR/IVDR)
- Supplier Evaluation & Control
Your product is only as strong as your supply chain:
- Identify critical suppliers
- Assess compliance
- Set up quality agreements and audit plans
- Design Reviews Don’t skip the checkpoints: Identify critical suppliers Assess compliance Set up quality agreements and audit plans
- Conduct formal reviews at key stages
- Include cross-functional input (R&D, QA/RA, clinical, etc.)
- Document decisions and actions
Milestones:
- Design inputs and risk management plan approved
- First prototype developed and verified
- QMS implemented and documented
- SOPs established and PRRC assigned (if applicable)
- Supplier evaluation completed
- Design review(s) conducted and documented
Why This Matters for Startups:
This is where your idea becomes real—and where regulators start paying close attention. A solid QMS isn’t just a compliance checkbox; it’s your operational backbone. And trust me, future you (and your investors) will thank you for getting it right early.
Phase 4: Clinical Evaluation & Technical Documentation
– T-minus Zero: Go for Launch
You’ve built it. Now it’s time to prove it’s safe, it works, and you’ve got the paperwork to back it up. This phase is where clinical evidence meets documentation discipline—and yes, it’s as important as it sounds.
What’s the Goal?
Generate the necessary clinical evidence and compile the technical documentation required for regulatory approval—whether you’re aiming for CE marking, FDA clearance, or another market entry.
Key Activities:
- Clinical Evaluation
Conduct a Clinical Evaluation in line with regulatory expectations:- Use data from literature, clinical investigations (if needed), and equivalent devices
- Demonstrate safety and performance (or analytical and clinical performance for IVDs)
- Prepare a Clinical Evaluation Report (CER)—or a Performance Evaluation Report (PER) if you’re working with an in vitro diagnostic (IVD).
(Think of PER as the IVD cousin of CER—same purpose, different focus.)
- Clinical Investigation (if applicable)
If your device needs fresh clinical data:- Plan and conduct a clinical investigation
- Obtain ethics and regulatory approvals
- Monitor and report adverse events
- Document everything (yes, again)
- Compile Technical Documentation
Structure your documentation to meet the requirements of your target market:- Device description and specifications
- Design and manufacturing information
- Risk management documentation
- Verification and validation data
- Labeling and instructions for use
- Clinical Evaluation Report (CER) or PER
- Post-market surveillance or performance follow-up plans
- General safety and performance requirements (or equivalent, depending on region)
- Prepare for Regulatory Review
- Ensure everything is complete, consistent, and review-ready
- Submit to a regulatory authority or notified body (if required)
- Be ready to respond to questions or non-conformities
Pro tip: This phase isn’t just about ticking boxes—it’s about building trust. Your technical documentation is what regulators, partners, and future auditors will rely on. Make it clear, complete, and compelling.
Milestones:
- Clinical Evaluation Report (CER) or PER completed and approved
- Clinical investigation (if required) completed and reported
- Technical Documentation compiled and reviewed
- Safety and performance checklist completed (aligned with your market’s requirements)
- Submission to regulatory authority or declaration of conformity prepared
Why This Matters for Startups:
This is where your product earns its regulatory passport. Strong documentation and clinical evidence don’t just get you to market—they build confidence with investors, partners, and customers. And yes, they can absolutely become part of your IP value.
Phase 5: Market Authorization & Product Launch
– We Have Liftoff!
You’ve done the hard work—now it’s time to get that official thumbs-up and bring your device to the world. This phase is all about regulatory approval meets go-to-market hustle. Think of it as your product’s debut party… with paperwork.
What’s the Goal?
Obtain regulatory approval (e.g., CE marking, FDA clearance, etc.) and successfully launch the product in prioritized markets.
Key Activities:
- Conformity Assessment Completion
- Submit technical documentation to the relevant authority or Notified Body (for higher-risk devices)
- Respond to questions, non-conformities, or requests for additional info
- For low-risk devices, prepare a self-declaration of conformity (requirements vary by region)
- Regulatory Approval & Declaration of Conformity
- Once conformity is confirmed, affix the appropriate regulatory mark (e.g., CE, UKCA, etc.)
- Sign and archive the Declaration of Conformity
- Ensure labeling and Instructions for Use (IFU) meet local regulatory requirements
- Device Registration
- Register the device in applicable databases (e.g., EUDAMED, FDA GUDID, national systems)
- Ensure economic operators (Authorized Representative, Importer, Distributor) are also registered and ready
- Market Readiness
- Finalize distribution and logistics plans
- Confirm readiness of economic operators
- Prepare marketing and sales materials that align with approved claims (no wild promises!)
- Launch Execution
- Launch in prioritized markets based on regulatory clearance and business strategys
- Monitor early feedback, support users, and be ready to adapt
Pro tip: Launching isn’t just about hitting “go”—it’s about being ready to scale, support, and shine. Make sure your team, partners, and materials are aligned and launch-ready.
Milestones:
- Regulatory certificate issued or self-declaration completed
- Declaration of Conformity signed and archived
- Device registered in applicable systems
- Product labeling and packaging finalized
- Distribution and launch strategy executed
Why This Matters for Startups:
This is the moment your innovation becomes a real-world solution. A smooth, well-documented launch shows investors that your team can execute—not just build. It signals market readiness, regulatory maturity, and the ability to generate revenue. In other words: it’s where your product starts proving its commercial value.
Phase 6: Post-Market Activities & Lifecycle Management
– On Orbit. Initiating Mission Operations.
Congrats, your device is out in the world! 🎉 But now comes the part where you keep it safe, effective, and compliant—for the long haul. Think of this phase as your product’s ongoing wellness check.
What’s the Goal?
Ensure continued compliance, monitor product performance in the real world, and manage updates or improvements throughout the product’s lifecycle.
Key Activities:
- Post-Market Surveillance (PMS)
- Implement the PMS plan you crafted earlier
- Collect and analyze real-world data on safety, performance, and user experience
- Use tools like complaints, incident reports, and user surveys (yes, feedback matters!)
- Periodic Safety Update Report (PSUR)
- Required for higher-risk devices (e.g., Class IIa and above)
- Include:
- Summary of PMS data
- Benefit-risk assessment
- Sales and usage data
- CAPA actions taken (Basically, a health report for your device.)
- Vigilance & Incident Reporting
- Report serious incidents and field safety corrective actions (FSCA) to authorities
- Maintain a vigilance procedure as part of your QMS
- Be proactive—regulators love that
- Regulatory Surveillance
- Stay updated on changes to regulations, standards, and guidance
- Update your documentation and processes accordingly
- Change Management
- Use a formal process to manage:
- Design changes
- Manufacturing updates
- Labeling or IFU revisions
- Management Review & Continuous Improvement
- Regularly review:
- QMS effectiveness
- PMS outcomes
- Regulatory updates
- Identify opportunities to improve your product or processes
(Yes, even great devices can get better.)Pro tip: Post-market activities aren’t just about staying compliant—they’re about staying competitive. Listening to users and adapting smartly is how good products become great.
Always evaluate the regulatory impact before making changes—it’s the difference between a smooth update and a surprise audit.
Milestones:
- PMS system operational and data collection ongoing
- First PSUR submitted (if applicable)
- Vigilance system in place and tested
- Regulatory updates reviewed and documented
- Management Review conducted and actions tracked
Why This Matters for Startups:
Post-launch is where your product earns long-term trust. A strong lifecycle management strategy shows investors that you’re not just building a device—you’re building a sustainable business. It signals maturity, foresight, and a commitment to quality that scales.
The Price of Progress (and Paperwork)
“No one can do everything, but everyone can do something — and together we can change the world.”
That’s the spirit behind the 6-phase journey I’ve just shared. Because let’s face it—bringing a medical device to market is a moon mission with budget reviews. And a pricey one at that.
But when you break it down, the chaos becomes strategy. The cost becomes investment. And the paperwork? Well… it becomes your IP.
Key Takeaways for Startups:
- Strategy & Classification
Get this wrong, and everything else gets more expensive. - Regulatory Planning
Know your markets. Surprises are for birthdays, not audits. - Product Development & QMS
Build it right, document it better. - Clinical Evaluation & Docs
Prove it works. Then prove you proved it. - Market Authorization & Launch
Time to shine—just don’t forget to register everything. - Post-Market & Lifecycle
Compliance doesn’t end at launch. It’s a lifestyle.
Each phase adds value. Each step reduces risk. And together, they show investors that you’re not just building a product—you’re building a business that’s ready to scale.
We are here to help. Use our specialists to navigate through the regulatory maze.