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ITMC Systems:US FDA Consulting for Medical Device and IVD Manufacturers

US FDA Consulting for Medical Device and IVD Manufacturers

ITMC Systems is a leading consulting firm dedicated to providing comprehensive US FDA consulting services for medical device and in vitro diagnostic manufacturers. With over 15 years of experience, our team of regulatory experts, former FDA professionals, and industry veterans is committed to guiding clients through the complex regulatory landscape with precision and expertise.

Our FDA consulting Services

Regulatory Strategy Development

  • Classification assessment and regulatory pathway determination
  • Tailored strategies for 510(k), PMA, De Novo, and other submissions.
  • Roadmaps for successful FDA clearance or approval.

Regulatory Submissions

  • Complete preparation, thorough review, and strategic submission of 510(k), PMA, De Novo, IDE, and more.
  • Ensuring submissions meet FDA requirements and standards.

Quality Management System (QMS) Support

  • Comprehensive QMS development, optimization, and implementation aligned with 21 CFR Part 820.
  • Internal audits, CAPA plans, and continuous improvement strategies.

Clinical Trial Management

  • Expert guidance in designing robust clinical trial protocols and endpoints.
  • Site selection, monitoring, data collection, and statistical analysis.

Labelling and Advertising Compliance

  • Rigorous review of labeling, packaging, and promotional materials for FDA compliance.
  • Ensuring accurate representation of product claims and regulatory information.

Risk Management and Post-Market Surveillance

  • In-depth risk assessments, analysis, and risk mitigation planning.
  • Development of comprehensive post-market surveillance strategies.

FDA Meeting Preparation and Representation

  • Strategic support in preparing for FDA meetings, including briefing document preparation.
  • Professional representation during meetings to address FDA inquiries.

Validation and Testing Support

  • Customized testing protocols for performance, safety, and usability assessments.
  • Verification and validation assistance to meet rigorous FDA standards.

International Regulatory Strategy

  • Global market entry strategies and guidance on international regulatory compliance.
  • Expertise in navigating diverse international regulatory requirements.

Compliance Training

  • Tailored training programs to educate teams on FDA regulations and best practices.
  • Workshops, webinars, and on-site training for comprehensive learning.
  • FDA Form 483 Warning Letter analysis, response, and recovery
  • QSR (21 CFR Part 820) audits for medical device companies and their suppliers
  • FDA QSR Consulting (21 CFR Part 820) for medical device and IVD manufacturers
  • FDA Requests for Classification and Requests for Determination
  • FDA Investigational Device Exemption (IDE) submissions for US clinical studies

Why Choose Us

At ITMC Systems, we believe in simplifying the regulatory journey for medical device and IVD manufacturers, ensuring compliance, and enabling successful market entry. Contact us today to partner with experts who understand your regulatory needs.

  • Unparalleled expertise in FDA regulations and medical device/IVD industry practices.
  • Proven track record of successful FDA clearances and approvals across diverse product categories.
  • Customized solutions based on clients' unique products and regulatory challenges.
  • Strong commitment to clear communication, project timelines, and client satisfaction.
  • Transparent pricing models and dedication to exceeding client expectations.
  • Our FDA consulting and project management teams coordinate efforts to deliver your services on time and within budget.
  • We offer effective FDA regulatory support for all sizes of firms, from small, start-up medical device companies to large, multi-divisional corporations.
  • We maintain constant accessibility and support both on- and off-site during the course of your FDA consulting project.

Our Clients

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