Evidence That Accelerates Your Growth
Clinical Evidence, Validation, Approval Pathways and Surveillance for Regulated Health
We work with medical devices, diagnostics, therapeutics, software-as-a-medical device, remote monitoring tools, and biopharma.
Clinical proof. Regulatory clarity. Market success.
At Interro, we provide:
End-to-end clinical study design & execution: Pilot, Human Factors & Usability, Validation, Retrospective, Comparative Effectiveness, Real-World Evidence, Surveillance, 510(k), and Pivotal Trial.
Evidence packages that build trust: Compelling safety and effectiveness data packages for investors, payers, and key opinion leaders.
Regulatory strategy & submission support: FDA, CE, 510(k), De Novo, PMA, IND, NDA, and Breakthrough.
Data & analytics: Biostatistics & data management compliant with 21 CFR Part 11.
Ethics & Institutional Review Board management: in-house for rapid execution.
From strategy to post-market, Interro HEP accelerates every regulatory milestone.
Why Choose Interro Health Evidence Partner?
Clinical Evidence That Moves the Needle: Generate the high-quality, publication-ready data needed for FDA submissions, payer negotiations, and investor confidence.
Regulatory-Savvy Study Design: Our protocols are built with regulatory expectations in mind - streamlining your path to approval.
Speed Without Sacrificing Rigor: Accelerate your time to market with lean studies that meet compliance standards and deliver clear endpoints.
End-to-End Validation Support: From feasibility to data dissemination, we guide you through every stage of your validation journey.
Integrated Expertise Across Modalities: Whether it’s a connected device, AI/ML-based software, biopharma, or a combination product, we understand the nuances of your technology.
Experienced with Early-Stage and Scaling Teams: We act as an extension of your internal team, flexibly adapting to your phase of growth and resource constraints.
Credibility That Opens Doors: Our data packages are designed to withstand scrutiny - from regulators, payers, providers, and strategic partners.
Specialized in Complex Compliance Environments: Deep experience with HIPAA, 21 CFR Part 11, ISO 14155, GCP, and other critical frameworks.
Research Funding From
Our team has secured grants and conducted projects funded by these federal agencies.
Who We Help
Medical device startups seeking FDA clearance
Software-as-a-medical device companies requiring clinical validation
Biopharma teams needing support or trial execution
Diagnostic or therapeutic companies preparing to fundraise
Interro HEP is built for fast timelines, lean budgets, and regulatory-savvy protocols.
Free Evidence Strategy. Clear Pricing.
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