Gain Peace of Mind and Build Investor Trust with Independent Expert Reviews — Tailored to Your Product’s Development Stage and Regulatory Strategy.
When your team is preparing for clinical trials, regulatory submissions, or a major investment round, external scientific validation is critical. Whether you're building a Class II medical device or innovating in advanced instrumentation, internal bias or gaps in experience can stall your progress or increase risk.
Our model connects you with experienced scientific leaders and regulatory experts to independently validate your work — from design files to test strategies — so your leadership, auditors, and investors can proceed with confidence.
● Scientific rationale & methodology;
● Technical feasibility (data flow, signal, hardware);
● Integration potential with clinical/lab workflow.
● Workflow analysis for patient/clinician
● Labeling, UI, and instructions feedback
● Use-Related Risk Analysis (URRA) input
● Design History File (DHF), requirements matrix, and architecture diagrams
● Verification plans and design input/output traceability
● Risk analysis (FMEA), fault tree, and mitigation strategies
● 510(k) summary, intended use, and predicate justification
● Labels, Instructions for Use (IFU), and regulatory classification
● Regulatory strategy alignment for FDA, CE, and ISO 13485
● Enclosure design, thermal management, material selection, and tolerancing
● Design for manufacturability (DFM) and design for assembly (DFA)
● Review of moving parts, connectors, and safety-critical elements
● Schematic verification, component placement, and power integrity
● PCB layout review for EMI/EMC, trace routing, and grounding
● Connector interfaces, firmware architecture (high level), and manufacturability
"I need a third-party review of our submission package before FDA filing."
"We want expert validation before committing to manufacturing."
"Our team needs feedback on technical risk and documentation."
"Investors asked for outside scientific oversight."
"We’re launching a study and want an expert to review our design logic."
We match your project with top-tier industry and academic leaders — professors, experienced directors of R&D, and regulatory experts with decades of experience in medtech, diagnostics, or scientific instrumentation.
You get real credibility, not just opinion.
👉 Book a free 30-minute intro call or Describe Your Project, and we’ll provide the Best Validation Option.
The Applied Science
The Applied Science is a registered partnership based in Ontario, Canada. We specialize in peer-reviewed consulting, technical validation, and regulatory support for medical devices, diagnostics, and scientific instrumentation. As a platform built by scientists, we consult MedTech, biotech, and engineering innovators. Our services include usability testing, feasibility analysis, risk reviews, and regulatory compliance consulting, all backed by senior scientific oversight. We support startups, scale-ups, and manufacturers across Canada and the United States with flexible delivery models — remote, on-site, or hybrid. Trusted by founders. Refer us to your investors. Recommend this platform to your clients. This is the go-to destination for expert-led product development, scientific guidance, and MedTech success.
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contact us at myappliedscience@gmail.com