Our Services

Expert Support for Regulated Medical Products

At RESQ Solutions, we provide actionable, customized support to help you navigate regulatory requirements, streamline product development, and build quality systems that last. Our services are designed for medical device, biotech, and pharmaceutical companies across all stages of growth.

  • Regulatory Submissions (FDA & CE)

    We help you bring your products to market with precision and confidence.

    FDA 510(k), De Novo, and PMA Submissions

    Emergency Use Authorizations (EUA)

    Pre-Submission (Q-Sub) Strategy & Execution

    CE Marking Support under EU MDR & IVDR

  • Quality Management Systems (QMS)

    Build a scalable, compliant quality system aligned with your business goals.

    ISO 13485 QMS Development & Implementation

    QMS Gap Assessments & Remediation

    Design Controls, Risk Management & CAPA Systems

    Audit Readiness & Continuous Improvement Programs

    We partner with your team to create systems that work in real-world environments, not just on paper.

  • ISO Audit & Certification Support

    Stay ahead of regulatory expectations with comprehensive audit support.

    Mock Audits (ISO 13485, MDSAP, FDA)

    Audit Response & Remediation

    Internal Auditor Training & Coaching

    Notified Body & Registrar Coordination

    As a former Lead Notified Body Auditor, our founder understands what auditors want — and how to prepare you for success.

  • Product Evaluation & Regulatory Strategy

    Avoid missteps early with expert strategic input on your product pipeline.

    Regulatory Pathway & Classification Analysis

    Risk-Based Product Evaluations

    Pre-clinical Safety Assessments

    Medical Device Clinical Evaluation Support- performed by a MD, FASA and former FDA/EU Clinical Evaluator

    Biocompatibility Testing Strategies

    Sterilization, Biocompatibility & Reprocessing Assessments

    Design History File & Technical File Reviews

    Make informed decisions with guidance grounded in decades of product experience across Class I–III and combination products.

Let’s Talk About Your Next Milestone

Every project is unique. Whether you're launching your first product or expanding into new markets, RESQ Solutions is here to guide you with confidence and clarity.