Course Overview
This course provides comprehensive training on the US FDA Quality System Regulation (QSR) for medical devices, focusing on critical aspects such as design controls, verification & validation (V&V), document management, and risk-based decision making.
Proper adherence and documentation of teh FDA's Design Control and Validation requirements are key to any medical product project's success.
This seminar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new product development under 21 CFR 820.30, "Design Control", and ISO 13485 7.3. Design Verification and Validation, Mandatory Device Safety/Risk and "as needed" Human Factors are also discussed. Also regulatory compliance proof of "progress against plan", and other activities requiring a planned documented rationale. It should be an important part of a company's IP (Intellectual Property). Follow the 10 required steps (both US FDA and EU MDR) to design control compliance in R&D. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project. Regular use can contribute greatly to reduction of scheduling uncertainty, incomplete projects when time is running out, increased product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.
Why Should You Attend
The FDA expects companies to manage the regulatory requirements of design control, and verification/validation with consideration of all applicable standards. How can the FDA's Design Control requirements, 21 CFR 820.30, which include a V&V component, actually facilitate this? The EU MDR and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader ensure critical elements are not omitted until late in the project when disaster looms? How does this translate into better, safer product in the field. Growing high-profile field problems indicate that much design control is perfunctory, poor or non-existent. Service Risk Management ad Files are an FDA requirement in this process. Human Factors / Use[ability] Engineering is also required in design if the device "interface" applies.
Course Agenda
Day 01
Session 1: Medical Device Development – Design Control and US FDA CGMPs and EU MDR / ISO 13485
- Introduction
- Design Control Under 21 CFR 820.30
- Design and Development Planning under ISO 13485:2016 7.3
- The U.S. FDA's DHF
- The EU MDR's D&DPF
- MDR's "General Safety and Performance Requirements"
- Device Classification -- U.S. FDA vs. EU MDR
- Design Files' "Typical" Contents
- The US DMR and DHR / Lot / Batch Record; the EU Versions
- TD Expected Contents
- The Future / Trends
Session 2: Medical Device Development – Risk Management
- Risk Management / File Under ISO 14971 - Device and QMS
- Narrative
- Hazzard Analysis
- FTA
- D-, P-, and U-FMECA's; Review – Residual Risk, Benefit / Risk Analysis
Session 3: Medical Device Development - Human Factors / Use Engineering
- Human Factors / Use Engineering Under IEC 62366-1:2015, -2:2016
- The User Interface
- The 9 Stages
- The HF / UE File
Summary
Review; Q & A
Day 02
Review of Day One
Session 4: Master V& V Planning
- V&V; “Working” Definitions
- Key Areas in Product Validation
- Key Equipment, Process, Software and QMS V&V Activities
- The Master Validation Plan
- Requirements
- Protocols / Test Cases; Proving (V&V) the Requirements
- DQ, IQ, OQ, PQs, and PPQs
- The Test Report
- Life Cycles; Regulatory “Hot Buttons”
Session 5: Software Verification and Validation
- Documentation – The 10 Elements “Model” “Rule”
- V&V “Models” – For the 4 Types of SW Validations, including 21 CFR Part 11, “Electronic Records / Signatures”
- Legacy, Hybrid, New and ER / ES Systems
- Life Cycle and “Cloud” Considerations
- Types of Testing; “Typical” Test Report and Test Case Samples
- GAMP® 4 & 5
- IEC 62304
Session 6 - Data Integrity and Cybersecurity
- Data Integrity and Cybersecurity – US FDA Requirements
- FDA Guidance Documents
- US NIST Recommendations
- Software Updates
- Software Patches
- The System Administrator
- Further Validation Considerations
Summary / Review Day 1 & 2 and Q&A
END Day Two
✅ Who Will Benefit
This seminar is designed to provide valuable guidance for regulated companies seeking to ensure full compliance with the design control requirements of:
- US FDA 21 CFR 820.30
- ISO 13485 – Section 7.3
- cGMP
- EU MDR / CE-Marking Compliance
Participants will learn about the 10 key design control milestones and practical examples that can be immediately applied to improve compliance and product development processes.
✅ Applicable Industries:
- Medical Device Manufacturers
- Combination Products Companies
✅ Ideal for Employees Involved In:
- Senior Management
- Regulatory Affairs
- Quality Assurance / Quality Assurance Engineering (QAE)
- Production
- Research & Development (R&D)
- Engineering
- Any personnel tasked with new or changed device development
This course empowers professionals to successfully implement design controls, verification, and validation strategies in line with regulatory expectations, reducing compliance risks and improving product safety and effectiveness.
Hear from Our Learners: Real Success Stories in FDA QSR & Design Control Training
⭐⭐⭐⭐⭐
"Extremely valuable and practical course!
This training provided crystal-clear insights into FDA 21 CFR 820.30 and ISO 13485 design control requirements. The examples and real-world case studies made it easy to understand how to apply design controls and verification & validation practices in our medical device development processes. Highly recommended!"
– Quality Assurance Manager
⭐⭐⭐⭐⭐
"A must-attend for Medical Device Professionals
The seminar gave me a solid understanding of design control milestones and how to implement them effectively under cGMP and EU MDR compliance. The instructor provided actionable examples that we immediately applied in our product development lifecycle."
– Regulatory Affairs Specialist
✅ Frequently Asked Questions (FAQ)
Q1: Who should attend this course?
A: Ideal for QA/QAE, Regulatory Affairs, R&D/Engineering, Production, and Senior Management involved in medical device or combination product development.
Q2: What will I learn?
A: You will learn FDA 21 CFR 820.30 and ISO 13485 design control requirements, the 10 key design control milestones, and practical strategies for verification & validation.
Q3: Are prior statistics or regulatory experience required?
A: No prior experience is required, but familiarity with medical device development processes is helpful.
Q4: How is the course delivered?
A: Online via live interactive sessions with case studies, examples, and practical exercises.
Q5: Will I receive a certificate?
A: Yes, participants receive a Certificate of Completion after finishing the course.
Faculty John E Lincoln
Principal, J E Lincoln and Associates (USA)
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.
