Medical Device Regulatory Compliance, Auditing, and QMS Support Without Premium Fees
Trusted experts helping medical device companies meet FDA 21 CFR 820, ISO 13485, EU MDR, MDSAP, and IEC 62304 requirements through internal audits, mock inspections, and quality system implementation — at consulting fees lower than typical industry standards, making high-value regulatory support more accessible for small, startup, and midsize manufacturers.
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Who We Are
FDAmedix is a dedicated consulting and quality-assurance firm specializing in regulatory compliance, auditing, and training for medical device manufacturers. We help companies navigate complex regulatory landscapes, including compliance with United States Food and Drug Administration (FDA) regulations, ISO standards, and European regulatory frameworks — enabling safe, effective, compliant medical devices reaching the market.
Why FDAmedix?
Lower-Than-Industry-Standard Consulting Fees: We deliver expert regulatory and quality consulting at more affordable rates than typical industry pricing, helping small, startup, midsize and growing medical device companies access high-quality compliance support without excessive consulting costs.
Proven Regulatory & Audit Success: We have supported dozens of organizations in achieving and maintaining compliance with ISO 13485, FDA QSR (21 CFR Part 820), MDSAP, and CE / EU MDR, including successful certification audits, regulatory inspections, and notified body assessments.
What We Do
Regulatory & Quality Consulting: We support clients in implementing and maintaining quality management systems (QMS) aligned with FDA QSR (21 CFR Part 820), ISO 13485, EU MDR/IVDR, IEC 62304 and other relevant standards.
Mock Audits & Inspection Readiness: Through mock audits, we simulate FDA or regulatory inspections to help you assess internal readiness, identify gaps, and remediate potential issues before actual inspections.
Remote & Internal Audits: Whether you’re in early design stages or preparing for certification/recertification, we offer baseline gap assessments, internal audits, supplier audits, remediation support — tailored to your needs.
Training & Education: We provide auditor training (including for ISO 13485 and MDSAP), risk-management guidance, CAPA/Root Cause Analysis, cybersecurity compliance, and more — empowering your team to uphold regulatory standards effectively.
Our Mission
We believe that rigorous quality systems, transparent regulatory compliance, and proactive preparation are the foundations of safe and effective medical devices. Our mission is to be the trusted partner for medical-device companies — guiding them through regulatory complexity, safeguarding patient safety, and enabling reliable, high-quality healthcare products worldwide.
Our Approach
Tailored & Flexible Services: Whether you need a full QMS build-out, a pre-inspection readiness check, or targeted supplier audits — we customize our services to fit your company’s size, regulatory history, and product types.
Remote and On-site Options: Recognizing the global nature of medical-device manufacturing, we offer both remote audits and in-person assessments to meet clients wherever they are.
Expertise & Experience: Our auditors and consultants bring deep regulatory knowledge, practical experience, and a proactive mindset — striving to help you not just pass inspections, but embed long-term quality and compliance.
Technical Documentation Development
We build or update technical files and design dossiers that meet MDR and Notified Body expectations. This includes developing comprehensive labeling, Instructions for Use (IFU/eIFU), device descriptions, and safety and performance documentation. We ensure all technical documentation is well-structured, traceable, and fully ready for regulatory review.
Notified Body Preparation & Support
We guide you through the Notified Body selection, application, and review process. Our experts help prepare technical documentation packages, respond to review comments, and ensure your submissions meet the latest MDR and MDCG guidance expectations. We act as your strategic partner during every stage of conformity assessment.