Solutions
FDA Pre-Market Submission Review
For medical device manufacturers, obtaining FDA approval is a critical step in bringing a product to market. The software components of these devices, whether as part of Software in Medical Devices (SiMD), Software as a Medical Device (SaMD), or Multiple Function Devices, are subject to rigorous regulatory scrutiny. Ensuring that software meets FDA requirements is essential to gaining approval and avoiding costly delays. Qualified Data Systems (QDS) offers a specialized FDA Software Pre-Market Submissions Review Solution tailored for medical device manufacturers. Our solution provides comprehensive review and support services to ensure that your software-related submissions meet all regulatory requirements, facilitating a smoother path to market approval.
Solution Activities
Regulatory Requirements Analysis
- FDA Guidance Compliance Review: QDS begins by reviewing your software development and documentation practices to ensure alignment with FDA guidance, including the General Principles of Software Validation, 21 CFR Part 820 (Quality System Regulation), and specific guidance for SaMD, SiMD, and Multiple Function Devices. Our experts analyze your processes to ensure they meet all applicable requirements.
- Risk Classification and Documentation: We assist in determining the appropriate risk classification for your software and ensuring that your documentation accurately reflects this classification. QDS helps you prepare the necessary documentation to support the software’s risk level, ensuring that it meets FDA expectations for safety and efficacy.
- Software Documentation Gap Analysis: Our team conducts a detailed gap analysis of your existing software documentation, identifying any areas that may fall short of FDA requirements. We provide actionable recommendations to address these gaps, ensuring that your submission package is complete and compliant.
Comprehensive Submission Package Review
- Software Requirements and Design Documentation: QDS reviews your Software Requirements Specification (SRS) and Software Design Specification (SDS) documents to ensure they are comprehensive and meet FDA expectations. We verify that all design controls, including traceability matrices, are properly documented and aligned with regulatory requirements.
- Verification and Validation (V&V) Review: We conduct a thorough review of your software verification and validation (V&V) documentation, including test plans, protocols, and reports. QDS ensures that your V&V activities are clearly documented and demonstrate that the software meets its intended use and risk controls are effective.
- Risk Management Documentation: QDS assesses your risk management file, including your risk analysis, risk evaluation, and risk control measures, to ensure compliance with ISO 14971 and FDA requirements. We review your risk management activities to ensure they are fully integrated into the software development lifecycle and properly documented.
Cybersecurity Documentation Review
- Cybersecurity Risk Management: As part of our review, QDS evaluates your cybersecurity risk management documentation, ensuring that it meets FDA expectations as outlined in the FDA’s guidance on cybersecurity in medical devices. We help you demonstrate that your software is secure, protecting patient data and device functionality from cyber threats.
- Software Update and Patch Management Plans: We review your plans for managing software updates, patches, and vulnerability assessments, ensuring they are robust and meet FDA requirements. QDS ensures that your documentation clearly outlines how software updates will be managed post-market to maintain security and compliance.
- Incident Response and Recovery Plans: QDS assesses your incident response and recovery plans, ensuring that they are well-documented and align with FDA expectations. Our review ensures that your organization is prepared to respond to and recover from cybersecurity incidents in a manner that protects patients and complies with regulatory requirements.
Pre-Submission Consulting and Support
- Pre-Submission Package Preparation: QDS assists in preparing your pre-submission package, including all necessary documentation, summaries, and supporting materials. We help ensure that your package is organized, comprehensive, and addresses all FDA requirements, increasing the likelihood of a successful review.
- Interactive Review Support: QDS provides support during the interactive review process, helping you respond to FDA inquiries and requests for additional information. Our team assists in drafting responses, providing additional documentation, and addressing any concerns raised by the FDA.
- Regulatory Strategy Consulting: We offer strategic consulting services to help you develop a regulatory submission strategy that aligns with your product development timeline and business goals. QDS provides insights on how to navigate the FDA submission process effectively, reducing the risk of delays and rejections.
Training and Continuous Improvement
- Regulatory Compliance Training: QDS offers training programs to ensure that your team understands FDA requirements for software in medical devices. Our training covers key topics such as software validation, risk management, and cybersecurity, helping your team stay informed and compliant.
- Documentation Best Practices: We provide guidance on best practices for preparing and maintaining software documentation that meets FDA standards. QDS helps you implement standardized documentation practices that facilitate smoother regulatory submissions and audits.
- Continuous Improvement Programs: QDS assists in establishing continuous improvement programs that focus on enhancing your software development and documentation processes. Our programs help ensure that your organization remains compliant with evolving FDA requirements and industry best practices.
Industry Focus
QDS specializes in providing FDA Software Pre-Market Submissions Review solutions for the following sectors within the medical device industry:
- Class I, II, and III Medical Devices: Supporting manufacturers of all classes of medical devices, ensuring that software components meet FDA requirements and are fully documented for regulatory review.
- Combination Products: Assisting in the regulatory submission process for combination products that integrate drugs, biologics, and devices, ensuring that software components are compliant with both device and pharmaceutical regulations.
- In Vitro Diagnostics (IVDs): Providing specialized support for IVD manufacturers, ensuring that software components meet regulatory requirements and support accurate diagnostic results.
Value Proposition
QDS’s FDA Software Pre-Market Submissions Review Solution offers the following benefits:
Our solution ensures that your software meets all FDA requirements, reducing the risk of delays, rejections, and costly rework.
By thoroughly reviewing your documentation and providing strategic support, we help streamline the submission process, increasing the likelihood of a successful FDA review.
Our focus on risk management ensures that all potential risks are identified, documented, and mitigated, protecting patient safety and meeting FDA expectations.
QDS helps you demonstrate that your software is secure and prepared to handle cybersecurity threats, a critical aspect of FDA approval for modern medical devices.