Medical Devices (incl. IVDs & SaMD) with AI

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Regal Intel offers a full spectrum of regulatory consulting services for medical device manufacturers, ensuring seamless market access and compliance across global markets. Our expertise covers a wide range of devices, from traditional medical equipment to cutting-edge technologies like target enrichment kits and devices supporting vaccine development.

Full-spectrum support for global submissions (FDA 510(k)/PMA/IDE, EU MDR/IVDR, NMPA, PMDA, TGA, Health Canada), technical documentation (CERs/PERs), QMS (ISO 13485, FDA QSR, MDSAP), clinical evaluations, PMS, SaMD classification/validation, cybersecurity, and specialized support for IVDs, companion diagnostics, and devices supporting vaccine manufacture (e.g., target enrichment kits).

Navigating the diverse regulatory landscapes of global markets is crucial for medical device manufacturers. Regal Intel provides comprehensive regulatory strategy development and submission support for:

• FDA 510(k), PMA, IDE, and Q-Submissions: Ensuring successful submissions in the United States.
• EU MDR (2017/745) and IVDR (2017/746) Compliance: Guiding manufacturers through the complexities of European regulations.
• International Registrations: Assisting with submissions in China (NMPA), Japan (PMDA), Australia (TGA), Canada (Health Canada), and other global markets.
• eCTD Submissions: Streamlining the submission process with electronic common technical documents.
• Risk Classification and Regulatory Pathways: Determining the appropriate regulatory pathway for your device.

The transition to the EU MDR and IVDR presents unique challenges for medical device and IVD manufacturers. Regal Intel offers specialized consulting services, including:

• Gap Analysis and Remediation: Identifying and addressing gaps in your current quality systems.
• Technical Documentation Preparation: Ensuring compliance with MDR/IVDR requirements.
• Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs): Assisting with the development and maintenance of necessary reports.
• Notified Body Interactions: Guiding manufacturers through the certification process.
• Post-Market Surveillance (PMS) and Vigilance: Developing robust PMS and vigilance systems.

Regal Intel possesses specialized expertise in the regulatory requirements for target enrichment kits and medical devices used in nucleic acid-based diagnostics and vaccine development. Our services include:

• Regulatory Strategy for IVDs and Companion Diagnostics: Guiding manufacturers through the complexities of IVD regulations.
• Clinical Performance Evaluation and Validation: Ensuring accurate and reliable performance data.
• Software as a Medical Device (SaMD) Considerations: Addressing the regulatory aspects of software used in these devices.
• GMP Compliance for Nucleic Acid-Based Products: Ensuring manufacturing processes meet stringent quality standards.
• Assistance with devices that assist in vaccine manufacture: Providing regulatory expertise for products which contribute to the vaccine manufacturing process.

Maintaining a robust QMS is essential for medical device manufacturers. Regal Intel offers:

• ISO 13485 Implementation and Certification: Ensuring compliance with the internationally recognized standard.
• FDA 21 CFR Part 820 Compliance: Guiding manufacturers through the FDA's Quality System Regulation.
• MDSAP Certification: Assisting with the Medical Device Single Audit Program.
• Internal and Supplier Audits: Conducting thorough audits to assess compliance.
• Pre-Assessment and Mock Audits: Preparing manufacturers for regulatory inspections.

Ensuring the safety and performance of medical devices requires comprehensive clinical evaluation and post-market surveillance. Regal Intel assists with:

• Clinical Evaluation Planning and Execution: Developing and implementing clinical evaluation plans.
• Post-Market Surveillance (PMS) Plans: Developing robust PMS systems.
• Adverse Event Reporting and Vigilance: Ensuring timely reporting of adverse events.
• Risk Management (ISO 14971): Implementing effective risk management strategies.

Increasingly, medical devices incorporate software components. Regal Intel supports:

• SaMD classification and regulatory pathways.
• Software validation and verification.
• Cybersecurity and data privacy compliance.
• Regulatory strategies for AI/ML based SaMD.