Slide 1: MedTech Regulatory Submissions Made Easy
MedTech Regulatory Submissions Made Easy Presented By: Kyle Rose, Axel Strombergsson, and Jeff Hau
Slide 2: Session Agenda
1. Introductions 2. Regulatory Submissions: US & EU Session Agenda 3. FDA Pre-submissions: What, Why, When & How 4. QuickVault: A Modern Tool for Submission Success 5. Q&A
Slide 3: Jeff Hau
Jeff Hau Senior Director, Product Management at Veeva Systems → 17+ Years in Software Product Management → Software Engineering at University of Waterloo → Part of Two Successful Startups (One IPO, One Acquisition) → Product Innovation at Amazon prior to Veeva Systems → Loves to Build Product that D
Slide 4: Axel Strombergsson
Axel Strombergsson Vice President, QuickVault at Veeva Systems → In the MedTech Industry for 20+ Years → Master’s Degree in Mechanical Engineering, R&D → Later Focused on Device Commercialization and Operations → Direct Hands-on Involvement in 6 Startups → Vanderbilt University, Technology Transfer
Slide 5: Veeva is the global leader in cloud software for the life sciences industry
Veeva is the global leader in cloud software for the life sciences industry Founded 2007 « 1,400+ customers ¢ 7,000+ employees ¢ $3B+ revenue 140+ MedTech customers. 19 of Top 20 largest companies already using Veeva s mine BD Baxter Semen myriad. a Edwards Q«~ | ~sysmex. ¢ eeeee stryker QIAGEN #2 F
Slide 6: QuickVault modules: documents, quality events, training, design, risk, suppliers
→ Documents and Data → Quality Events (NCRs, CAPAs, Complaints) → Training Management → Design and Development (Design Controls) → Risk Management → Supplier Management → Regulatory Submissions* → Equipment Management**
Slide 7: QuickVault
QuickVault Easy OnBoarding = Easy Compliance = Easy-to-Use Solution Ready-Day-One Quick Start - Zero implementation costs. Zero maintenance costs. Includes Library of Resources Complete MedTech documentation package, SOP, eLearning, assessments, guides, & more! Fully Validated Always fully validated
Slide 8: Kyle Rose
Kyle Rose CEO & Founder, Rook Quality Systems → Quality and Regulatory consultant advising medical device companies around the world for over 12 years. → NIH lead for multiple programs including RADx supporting over 100 COVID diagnostic devices → Advisor to multiple Fortune 500 on all aspects of Qua
Slide 9: Rook Quality Systems
Rook Quality Systems MAKE EVERY MOVE COUNT Quality, Compliance, and Regulatory Support for MedTech Founded in 2012 Global Consulting Team 35+ Consultants 13 Certified Auditors *2 PhotoniCcare @ ZiphyCare ><) () CIRCADIA PE N U M AS XANDAR KARDIAN IMPLANT FOR MEN ag neossoma -HURA Sotera’ safeBVM Oe
Slide 10: Regulatory Submissions: US & EU
Regulatory Submissions: US & EU
Slide 11: What is a 510(k) Submission?
What is a 510(k) Submission? → The 510(k) process is a premarket submission to the FDA to demonstrate the device is safe and effective. - Uses a predicate method to demonstrate that the device under review is substantially equivalent to the predicate device. → Required for most Class II and some Cla
Slide 12: Content Of A 510(k)
Content Of A 510(k) → Administrative Information (Cover letter, contact details, FDA Form 3514) → Device Description (Intended use, technological characteristics) → Predicate Device Comparison (Side-by-side comparison of key features) → Performance Testing (Bench, animal, and/or clinical testing as
Slide 13: Submission Process for a 510(k)
Submission Process for a 510(k) → Identify Predicate Device - Must have similar intended use and technological characteristics. → Determine Appropriate 510(k) Pathway - Traditional 510(k): Standard pathway for most devices. - Special 510(k): For modifications to an existing cleared device (faster rev
Slide 14: Submission Process for a 510(k)
Submission Process for a 510(k) → Submit via FDA eSTAR Portal - As of October 1, 2023, eSTAR is required for all 510(k) submissions. → FDA Review Process (90 days) - Acceptance Review (15 days): FDA checks if the submission is complete. - Substantive Review (60 days): FDA evaluates the data and may
Slide 15: Best Practices for Submitting a 510(k)
Best Practices for Submitting a 510(k) → Start the FDA 510(k) planning as early as possible → Research predicate devices for everything they did including testing, instructions for use, packaging, device claims, and any post market feedback or complaints. → Software documentation is more thorough th
Slide 16: What is a De Novo Classification Request
What is a De Novo Classification Request → The De Novo process provides a pathway to classify novel medical devices that have no prior predicate but present low to moderate risk (Class I or II). → It is an alternative to automatic Class III classification, which would otherwise require a Premarket App
Slide 17: Key Content of a De Novo Submission
Key Content of a De Novo Submission → Administrative Information (Applicant details, device name, etc.) → Device Description (Intended use, technological characteristics) → Classification Summary (Justification for Class I or II classification) → Benefit-Risk Assessment (Safety and effectiveness data) →
Slide 18: Overview of the De Novo Submission Process
Overview of the De Novo Submission Process → Pre-Submission (Optional but Recommended) - Engage with the FDA for feedback on the regulatory pathway and study requirements. → De Novo Request Submission - Submitted after either: - A 510(k) submission receives a Not Substantially Equivalent (NSE) deter
Slide 19: Best Practices for Submitting a De Novo Request
Best Practices for Submitting a De Novo Request → Plant to meet with the FDA to determine the device classification, testing required, and claims. → Prior to meeting with the FDA you need to seek regulatory guidance to have a strategic plan to address all of the questions above and propose the path t
Slide 20: What is a PMA Submission?
What is a PMA Submission? → PMA = Pre-Market Approval → PMA process is the FDA’s most stringent regulatory pathway for medical devices. → Required for Class III devices, which present high risk and are life-supporting, life-sustaining, or of substantial importance in preventing impairment of human h
Slide 21: Key Content of a PMA Submission
Key Content of a PMA Submission → Administrative Information (Applicant details, device name, indications for use) → Device Description & Principles of Operation → Non-Clinical Testing (Bench, biocompatibility, electrical safety, software, sterilization, etc.) → Clinical Study Data (Human studies de
Slide 22: Overview of the PMA Submission Process
Overview of the PMA Submission Process → Pre-Submission (Optional but Recommended) - Engage with the FDA for guidance on study design, testing requirements, and data expectations. → PMA Submission - Includes comprehensive clinical, non-clinical, and manufacturing data. → FDA Acceptance Review (45 da
Slide 23: What is a CE Mark Submission?
What is a CE Mark Submission? → The CE Mark indicates that a medical device meets the regulatory requirements of the European Union (EU) and can be legally marketed in EU and EEA countries. → Medical devices are regulated under the EU Medical Device Regulation (MDR 2017/745) or In Vitro Diagnostic R
Slide 24: Key Content for a CE Mark Submission
Key Content for a CE Mark Submission → Device Description & Intended Use → Quality Management System (QMS) Documentation → Classification Justification (Per MDR/IVDR rules) - ISO 13485 certification required for Class IIa, IIb, and III → Technical Documentation (TD) / Design Dossier → Post-Market Surve
Slide 25: CE Mark Submission Process
CE Mark Submission Process → Device Classification (Class I, IIa, IIb, III) - Classification determines the regulatory pathway. - Higher-risk devices require Notified Body (NB) review. → Conformity Assessment - Class I (low-risk): Self-certification via a Declaration of Conformity (DoC). - Class IIa, II
Slide 26: CE Mark Submission Process
CE Mark Submission Process → Notified Body Review & Certification - NB audits the manufacturer’s Quality Management System (QMS) (ISO 13485 compliance). - NB issues a CE Certificate for Class IIa, IIb, and III devices. → Declaration of Conformity & CE Marking – Manufacturer issues a Declaration of Conf
Slide 27: Best Practices for Submitting a CE Mark
Best Practices for Submitting a CE Mark → Identify a notified body that has codes for your product type and specializes in your type of technology if possible → Prepare for both onsite quality audits as well as offsite technical review of the Technical File and Clinical Evaluation Report. → The EU MDR
Slide 28: FDA Pre-submissions: What, Why, When & How
FDA Pre-submissions: What, Why, When & How
Slide 29: FDA MedTech Pre-submission: What is it?
FDA MedTech Pre-submission: What is it? → Written request for feedback from FDA → Used to guide development and/or application preparation → Feedback received in 75-90 days → and lastly: it’s free! https://www.fda.gov/media/114034/download
Slide 30: FDA MedTech Pre-submission: What does it contain?
FDA MedTech Pre-submission: What does it contain? https://www.fda.gov/media/93740/download
Slide 31: FDA MedTech Pre-submission: Why does FDA want it?
FDA MedTech Pre-submission: Why does FDA want it? → Make the review process on faster → Learn about your device - many new devices are novel → Provide feedback to manufacturer’s early in the process → Provide guidance on required DV&V testing to ensure safe and effective devices https://www.fda.gov/
Slide 32: FDA MedTech Pre-submission: Why should you do it?
FDA MedTech Pre-submission: Why should you do it? → Significantly de-risks your regulatory strategy → The “handshake” with the FDA → Get to the market faster - less risk of rejection → Clear pathway for DV&V, including any clinical testing → Fundraising: de-risking for investors
Slide 33: FDA MedTech Pre-submission: When should you do it?
FDA MedTech Pre-submission: When should you do it? https://www.fda.gov/media/114034/download
Slide 34: FDA MedTech Pre-submission: When should you do it?
FDA MedTech Pre-submission: When should you do it? When you have: → A solid understanding of the design and how your device will be operating → Decided on intended use and indications for use → An assessment of device class → An assessment of pathway to market (510k, De Novo, PMA etc.) and any predi
Slide 35: FDA MedTech Pre-submission: How to do it?
FDA MedTech Pre-submission: How to do it? → Ensure you have someone very experienced by your side - Rook support → The words you are using are crucial - can be a risk if you say the wrong thing → Don’t ask open-ended questions - provide your thinking and let FDA respond → Provide information to easi
Slide 36: FDA MedTech Pre-submission: In summary
FDA MedTech Pre-submission: In summary → Don’t see this just “optional” - make sure you do it → Drastically de-risk your path to market → Provide confidence in your device testing plan → Promote marketing submission success (510k etc.) → Fundraising: de-risked for investors
Slide 37: QuickVault: A Modern Tool for Submission Success
QuickVault: A Modern Tool for Submission Success
Slide 38: Q/A
Q/A Kyle Rose Axel Strombergsson Jeff Hau Founder & CEO VP, Strategy Sr. Director, Product Management Rook Quality Systems QuickVault By Veeva QuickVault By Veeva kyle.rose@rookqs.com quickvault@veeva.com www.rookqs.com www.quickvault.veeva.com