Regulatory approval and commercialization for medical devices
A good Medical Device
is not yet a business.
URATIO helps medical device companies take their novel or established device through the clinical evaluation process, select the best claims for market revenue, tie in the available evidence and write the story for your regulatory body.
What we do
Four ways in
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Market entry
Which country, which regulatory routes are available and how to strategically get most out of the possibles within that market.
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Strategy and C-level input
Strategic advice from URATIO has a foundation in regulatory, complimented with market access and a lot of clinical know-how. Giving you due diligence directly to the C-level decisions that follow device development and post-market expansions.
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Pricing & business model
Multi patient or single use device can be designed for a pricing model in mind, the regulatory approval and post market surveillance should supplement the business model.
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Health care providers work, I have been there
Engagement with healthcare professionals can be uniform and unproductive, the interaction through URATIO is a mindset of a healthcare professional and the skills of a regulatory professional. URATIO will create documentation that explains your device knowledge and aspirations to regulators and end users.
Approach
Operator work, not a slide deck.
Engagements are short, scoped and hands-on. The output is a decision you can act on and the material to execute it — not a recommendation left on the table.
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Diagnose
You present the device, the documentation and the stakeholders involved. What is the issue to be fixed.
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Decide
We decide what is the best option for your device and URATIO creates the outcome needed.
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Deploy
URATIO can assist in submissions and meetings with regulatory authorities for all the does and don’t that come with submissions.
Founder
Søren Underbjerg
Ten years with medical devices, 3,5 years as a GP and the rest working as Senior regulatory advisor, with devices in all classes and technologies covering simple syringes to heart valves, and working a lot with Software as Medical Devices companies. URATIO is that experience offered directly, working alongside the founders and developers rather than above them.
Start a conversationExperience
Geographical location of stakeholders, experience across continents in project management and international etiquette.
Footprint
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Europe
UK, Germany, France, Belgium, Netherlands, Switzerland, Denmark, Norway, Sweden, Finland
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Asia
India, China, Japan
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Middle East
Israel, Saudi Arabia
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North America
USA
Documents
220+major regulatory documents delivered, 2020–2026
- Clinical Evaluation Plans (CEP) 86
- Clinical Evaluation Reports (CER) 74
- PMCF plans 24
- Risk management analyses 19
- PMS plans 17
All as lead author
Expertise & education
- 2018 BSc. Medicine, Aalborg University
- 2020 Cand. Med. Scient., Medical Market Access, Aalborg University 2020–2026 · Senior regulatory advisor
Standards
- MDR
- IVDR
- ISO 13485
- ISO 14971
- ISO 14155
- MDSAP
- FDA
- QMS
- Regulatory strategy
- Clinical development
- Market access EU & US
- Technical documentation
- Clinical evaluation
- Risk management
- Medical writing
- Quality management systems
- 2020–2026 Achievements & global MedTech experience
- Clinical evaluation expert
- Regulatory strategy lead
- Project manager
- Team lead, clinical development & market access
- Speaker, 9th EAAR Annual Conference (2025)
Tell me where the product is stuck.
A thirty-minute call is enough to say whether this is work I can help with.