Accelerating Regulatory Success: QuickStart QMS Package for MedTech Start-ups

This session explores the critical hurdles encountered by startup medical device (MedTech) companies as they navigate complex regulatory requirements and introduces the QuickStart QMS package, a collaborative solution developed by Rook Quality Systems and Veeva QuickVault. The core premise is that while startups recognize the need for a Quality Management System (QMS), simply implementing documentation is insufficient; success requires integrating modern software and expert guidance tailored to the company's specific operations. The speakers—Kyle Rose (Rook Quality Systems), Axel Strombergsson, and Jeff Hau (Veeva Systems)—share their extensive experience, emphasizing that foundational quality and regulatory planning must begin early in the product design lifecycle to ensure successful commercialization and avoid costly delays or compliance gaps.

The presentation establishes a three-pillar approach essential for MedTech startup success: a full QMS documentation package, leveraging modern eQMS software (QuickVault), and ongoing expert support and knowledge from consultants (Rook). Axel Strombergsson recounts his personal experience with a startup that implemented a QMS but lacked the context and adaptation necessary to operate compliantly, leading to difficulties during their first notified body audit. This anecdote underscores the necessity of customizing procedures to reflect day-to-day business operations. The QuickStart package bundles these three components—QMS templates, QuickVault access for three users, and five hours of monthly expert consulting—at a startup-friendly discounted rate, positioning it as an appreciating asset that develops over time without increasing subscription cost.

Jeff Hau provides a live demonstration of Veeva QuickVault, showcasing its out-of-the-box, fully validated electronic Quality Management System (eQMS) capabilities, which are compliant with applicable medical device regulations. The demo highlights simple, easy-to-use workflows for document control, including Part 11 compliant electronic signatures and automated PDF generation with appended approval pages. Key features include comprehensive training management (read-and-understood, batch assignments, curricula for automated training matrix management, and logging external training), and streamlined quality event workflows (quality issues, CAPAs, change controls, and effectiveness checks). A sneak peek of the upcoming design control and risk management module reveals automated design reviews, traceability linking user needs to design inputs, and the ability to export content to automatically generate the Design History File (DHF), Device Master Record, and risk reports. Kyle Rose reinforces the consulting value, noting that Rook helps companies define user needs, establish the regulatory path (including pre-submission meetings with the FDA), and plan verification and validation early to optimize timelines and funding.

Key Takeaways:

• Three Pillars of Regulatory Success: MedTech startups require a combination of robust QMS documentation, modern eQMS software (like QuickVault), and ongoing expert support (like Rook) to achieve and maintain compliance efficiently.
• QMS Customization is Crucial: Simply purchasing or implementing a generic QMS is insufficient; procedures must be adapted and customized to accurately reflect the company's specific product, business model, and day-to-day operations to avoid operating out of compliance.
• Early Regulatory Planning Mitigates Risk: Identifying the regulatory path, including classification and necessary testing, must be done early in the design phase to accurately plan timelines and funding, preventing significant delays (e.g., a missed test delaying submission by six months).
• Veeva QuickVault Value Proposition: QuickVault is offered as a fully validated, out-of-the-box eQMS solution, eliminating long configuration projects and the need for customers to reassess validation status during ongoing software updates, allowing companies to start operating compliantly immediately.
• Automated Training Management: The system supports advanced training features like Curricula, which automates the assignment of required documents based on roles (acting as an automated training matrix) and ensures users are automatically assigned new versions of documents upon approval.
• Integrated Quality Event Management: QuickVault provides tailored, actionable workflows for quality issues (deviations, incidents, complaints), CAPAs (with two-stage approval for plan and execution), and change controls, replacing cumbersome paper or Word document processes.
• Design Control Automation (Upcoming Feature): The new module will automate design reviews, allowing formal reviews to be conducted and documented directly within the system, linking user needs, design inputs, and risk assessments for complete traceability.
• Risk Management Integration: The system supports risk assessment (e.g., 5x5 matrix) and mitigation documentation, linking risks directly to design controls, and facilitating the export of comprehensive risk reports.
• Compliance Gaps and Consequences: Common pitfalls include incomplete Design History Files (DHF), failure to conduct annual internal audits/management reviews, using non-customized QMS procedures, and poor product quality, which can lead to FDA warning letters, company shutdowns, or reduced valuation during acquisition or fundraising due diligence.
• Startup-Friendly Model: QuickVault operates on a month-to-month subscription model, avoiding multi-year contracts that can be a barrier for early-stage companies facing cash flow challenges, and the company is committed to working with clients experiencing funding issues.
• Continuous Improvement Without Price Change: Veeva commits to continuous improvement and adding new functionality (like regulatory submission preparation tools) without increasing the subscription cost for existing QuickVault customers, making it an "appreciating asset."

Tools/Resources Mentioned:

• Veeva QuickVault: An electronic Quality Management System (eQMS) specifically built for MedTech startups, offering document control, training, quality events, and upcoming design control/risk modules.
• Rook Quality Systems: Consulting firm providing quality system design, regulatory submissions (US and International), software validation, risk management, and fractional quality management support.
• Veeva Systems: Parent company providing cloud-based solutions for the life sciences industry (quality, clinical, regulatory, commercial).
• ISO 13485: International standard for medical device quality management systems (mentioned as a standard Rook helps clients achieve).
• FDA 21 CFR Part 11: Regulation governing electronic records and electronic signatures (QuickVault is compliant).
• eSTAR: Electronic submission template used for FDA submissions (mentioned as future functionality for QuickVault).

Key Concepts:

• QMS (Quality Management System): The formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, essential for regulatory compliance in MedTech.
• eQMS (Electronic Quality Management System): Software used to manage quality and regulatory processes digitally, offering automation and centralized data storage.
• DHF (Design History File): A compilation of records that describes the design history of a finished medical device, crucial for regulatory submissions and audits.
• Design Controls: A set of quality practices and procedures integrated into the design and development process of a medical device to ensure the device meets user needs and intended use.
• 510(k): A premarket submission made to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device.
• CAPA (Corrective and Preventive Action): A system for investigating, documenting, and resolving nonconformities and preventing their recurrence.