Consulting & Strategy
Materials Metric offers comprehensive support for FDA compliance, including preparation for 510(k) submissions, De Novo applications, and Investigational Device Exemptions. We also assist with Premarket Approvals (PMA) and can guide the development of combination drug-device products. Our services extend to providing strategic testing guidance and developing biological evaluation plans and reports necessary for ensuring your product meets FDA and other regulatory standards.
US FDA Consulting
Navigating FDA regulations can be complex, but our expertise ensures a streamlined and efficient process. We assist with:
Regulatory Pathway Determination – Identifying whether your product requires a 510(k), De Novo, IDE, or PMA submission.
Regulatory Submissions & Compliance – Preparing comprehensive applications for FDA approvals, modifications, and clearances.
Pre-submission & FDA Meetings – Engaging with the FDA early to align your strategy and resolve potential roadblocks.
Quality System Compliance – Assisting with Good Manufacturing Practices (GMP), ISO 13485, and FDA QSR requirements.
Biological Safety Consulting
We help you develop a robust biological safety evaluation strategy in line with ISO 10993 and FDA expectations. Our services include:
Biological Risk Assessment (BRA) – Identifying potential risks and ensuring materials are safe for human use.
Extractables & Leachables (E&L) Testing – Evaluating chemical compounds that may migrate from materials into the body.
Toxicological Risk Assessments – Determining safe exposure limits and mitigating toxicological concerns.
Gap Assessments – Identifying missing data and defining a cost-effective testing plan.
Market Research
Bringing a new medical device or pharmaceutical product to market requires deep industry insights. Our market research services help you make data-driven decisions with:
Competitive Landscape Analysis – Identifying market trends, key competitors, and potential barriers.
Regulatory & Compliance Trends – Understanding evolving FDA and international regulations affecting your product.
Clinical & Commercial Viability Studies – Assessing demand, pricing models, and reimbursement pathways.
Patient & Physician Insights – Gathering feedback to optimize product positioning and adoption.