Press release
Nometech Oy launches compliance solutions that support MedTech startup funding
For many MedTech founders, the greatest challenge in fundraising is the "Regulatory Gap" the uncertainty that scares off lead investors. Without a clear roadmap for market entry, startups often face lower valuations or stalled funding rounds. Nometech's new service models are designed to turn this liability into a strategic asset.
Investors are looking for proof that a product is not just innovative, but deliverable. Our Kickstart products are designed to provide exactly that: a professional, audit-ready foundation that directly increases a startup's pre-money valuation.
The two solutions announced today are:
FDA Submission Kickstart: A streamlined approach for companies targeting the U.S. market. It provides a comprehensive gap analysis and a structured roadmap for regulatory submissions, ensuring the technical file meets FDA expectations from day one.
EU MDR Kickstart: Specifically designed to navigate the rigorous requirements of the European Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746).It helps startups establish the necessary technical documentation and quality foundations to achieve CE-marking without costly late-stage redesigns.
By utilizing these established frameworks, startup founders can demonstrate to Venture Capitalists and Angel Investors that they have a controlled, expert-backed path to market. This "Compliance by Design" approach eliminates the execution risks that typically plague early-stage MedTech companies.
Nometech Oy continues to act as the technical and regulatory backbone for healthcare innovators, providing the expertise required to navigate the complexities of global market entry.
For more information on how to de-risk your regulatory journey, visit https://nometech.eu
Nometech Oy
Salvostie 25F, 90540 Oulu, Finland
katja.koskinen@nometech.fi
Nometech Oy is a Finnish consulting firm specializing in medical device regulatory affairs and quality management systems. Based in Oulu, one of Europe's leading health-tech hubs, Nometech bridges the gap between complex engineering and global regulatory requirements.
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