iMDR MedTech – Simplifying Global Medical Device Compliance

Navigating Regulatory Complexity with Expertise

Bringing a medical device to market requires a deep understanding of global regulations, compliance strategies, and risk mitigation. At iMDR MedTech, we specialize in end-to-end regulatory consulting, helping MedTech innovators, manufacturers, and healthcare organizations accelerate approvals and ensure patient safety.

With 200+ regulatory experts worldwide, we provide a seamless pathway for regulatory approvals across multiple markets, ensuring your medical device meets all necessary safety, quality, and performance standards.

Our Expertise – Ensuring Compliance Across Global Markets

Regulatory Consulting & Compliance

We provide strategic guidance and hands-on support for compliance with:
✔ ISO & IEC Standards – Essential for medical device safety, performance, and quality
✔ USFDA – Premarket Notification (510(k)), PMA, De Novo, QSR, and post-market compliance
✔ ASTM – Industry-leading safety and performance standards for medical devices
✔ TGA (Australia) – Regulatory approvals for Australian market entry
✔ ANVISA (Brazil) – Compliance for medical devices in the Brazilian market
✔ PMDA (Japan) – Regulatory approval pathway for Japan
✔ EU MDR & IVDR – Ensuring compliance with European regulatory requirements

Whether you need pre-market approvals, quality management implementation, technical documentation preparation, or post-market surveillance, our experts provide tailored regulatory strategies that align with your market entry goals.

Our Core Services

Regulatory Strategy & Market Entry

✔ Regulatory Pathway Analysis – Identify the fastest and most cost-effective approval routes
✔ Gap Assessment & Risk Mitigation – Reduce compliance risks before submission
✔ Regulatory Submission Support – 510(k), PMA, CE Marking, TGA approvals, and more

Quality Management & Audits

✔ ISO 13485 & QMS Implementation – Build a robust, audit-ready quality management system
✔ Mock Audits & Gap Assessments – Prepare for USFDA, EU MDR, and ISO inspections
✔ Supplier Audits & Compliance Reviews – Ensure manufacturing compliance

Technical Documentation & Compliance Support

✔ Clinical Evaluation Reports (CERs) & Biological Evaluation Reports (BERs)
✔ Risk Management (ISO 14971) & Human Factors Engineering (IEC 62366)
✔ Labeling & UDI Compliance – Ensure global traceability and adherence

Post-Market Surveillance & Regulatory Maintenance

✔ Complaint Handling & CAPA Compliance
✔ Periodic Safety Updates & PMS Reports
✔ Regulatory Renewals & Compliance Monitoring

Why Choose iMDR MedTech?

✔ Global Reach, Local Expertise – Regulatory teams in the USA, EU, and Australia, with insights into regional and international requirements
✔ Comprehensive Solutions – From regulatory strategy to submission, audits, and post-market surveillance
✔ Accelerated Market Access – We help you reduce approval timelines and minimize regulatory roadblocks
✔ Client-Centric Approach – Personalized consulting tailored to your product and business goals
✔ Commitment to Quality & Safety – Enabling the launch of safe, effective, and compliant medical devices

Partner with iMDR MedTech for Regulatory Success

Ensuring compliance isn’t just about meeting requirements – it’s about delivering safe, effective medical devices to the world.

💡 Need expert regulatory guidance? Let’s discuss how we can help you achieve global compliance and bring your medical device to market faster.

📩 Contact Us Today at info@imdrmedtech.com

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