Navigate Your Regulatory Pathway with Confidence
Effectum Medical delivers expert-written reports on classification, applicable standards, and optimal approval routes—supporting both internal alignment and external fundraising.
Navigate Your Regulatory Pathway with Confidence
Effectum Medical delivers expert-written reports on classification, applicable standards, and optimal approval routes—supporting both internal alignment and external fundraising.
Regulatory Opinions
- Confirm classification and standards
- Choose the right regulatory pathway (EU, CH, UK, US)
- Align internally and with investors
- Prepare for MDR, IVDR, or FDA requirements
Whether you’re launching a new product or entering a new market, a regulatory opinion helps you:
- Expert analysis: Based on decades of hands-on experience
- Custom-tailored: Adjusted to your product and market
- Clarity for pitch decks & VCs: Avoid ambiguity during funding
- Applicable globally: Switzerland, EU, UK, and USA
Key Benefits
Team QMS | Camilla Messerli
Head of Quality Management & Regulatory Affairs
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What Clients Say
Uwe Siedler, SIGNUS Medizintechnik GmbH
They remained approachable at all times and were able to answer any questions that arose throughout the entire process.
Gian Nutal Schaedli, CompagOS AG
Their guidance gave us the confidence to establish a clear roadmap for regulatory approval, which we carried into our Venturekick Stage III pitch — and won.
Uwe Siedler, SIGNUS Medizintechnik GmbH
They remained approachable at all times and were able to answer any questions that arose throughout the entire process.
Gian Nutal Schaedli, CompagOS AG
Their guidance gave us the confidence to establish a clear roadmap for regulatory approval, which we carried into our Venturekick Stage III pitch — and won.