Training Features

FDA regulations for medical devices and IVD's: The Essentials

Join us on 11 and 18 May 2026 for a virtual training that will help you navigate FDA regulations and ensure compliance for medical devices and IVDs in the U.S. market.
Format

Virtual Training

Level

Basic

Date

11 and 18 May 2026

Time

14:00 - 18:00 CET

Duration

2 x 4 hours

Trainer

Tim Joiner

Certificate

Certificate included

Price

€ 1195 or equivalent currency

Navigating FDA Regulations for Medical Devices and IVDs

The U.S. Food and Drug Administration (FDA) regulates medical devices and in vitro diagnostics (IVDs) to ensure their safety, effectiveness, and quality before and after they reach the market. Understanding the regulatory framework of the FDA is crucial for manufacturers, regulatory professionals, and quality teams involved in bringing medical devices and IVDs to the U.S. market. 

Led by Tim Joiner, this interactive training provides an overview of FDA regulations, including key requirements for device classification, premarket submissions (510(k), PMA, De Novo), Quality System Regulation (QSR) compliance, post-market obligations, and enforcement actions. Participants will learn how to navigate FDA regulatory pathways and ensure compliance with U.S. requirements for medical devices and IVDs.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
Understanding the U.S. Food and Drug Administration (FDA) regulatory framework is essential for manufacturers, regulatory professionals, and quality teams to ensure the safety, effectiveness, and compliance of medical devices and in vitro diagnostics (IVDs).

This virtual training provides an overview of FDA requirements, including device classification, premarket submissions (510(k), PMA, De Novo), Quality System Regulation (QSR) compliance, post-market obligations, and enforcement actions. Participants will gain practical insights into navigating FDA regulatory pathways and learn how to maintain compliance throughout the product lifecycle.
Key Learning Objectives
  • Understand the FDA regulatory framework and classification system for medical devices and IVDs
  • Learn the key requirements for FDA premarket submissions, including 510(k), PMA, and De Novo applications
  • Gain insights into FDA quality system requirements (21 CFR Part 820) and how they compare to ISO 13485
  • Understand post-market surveillance, medical device reporting, and recall obligations under FDA regulations
  • Learn how to prepare for FDA inspections and avoid compliance issues
  • Explore the regulatory requirements specific to IVDs, including clinical validation and performance studie
  • Understand the enforcement actions the FDA can take and how to maintain compliance to avoid regulatory risks.
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in two sessions, lasting 4 hours each, providing a focused and efficient learning experience. The sessions will take place on 11 and 18 May 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, additional sessions will be held on 3 and 11 November 2026. More information can be found on the registration page.
Who Should Attend?
  • Regulatory Affairs professionals responsible for FDA submissions and compliance
  • Quality Assurance professionals ensuring compliance with FDA QSR (21 CFR Part 820)
  • Medical device and IVD manufacturers planning to enter or maintain U.S. market access
  • Clinical and R&D teams working on FDA-regulated medical devices and diagnostics
  • Post-market surveillance and vigilance teams handling FDA reporting obligations
  • Professionals responsible for FDA interactions, pre-submissions, and regulatory strategy
  • Senior management overseeing regulatory compliance for the U.S. market
  • Internal auditors evaluating FDA compliance readiness within their organization.
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Overview of the FDA regulatory framework, including the agency’s role, key U.S. laws (FD&C Act, 21 CFR), and differences between medical devices and IVDs.
  • Medical device classification and regulatory pathways, covering risk-based classes (I, II, III), 510(k) notifications, PMA approvals, De Novo pathway, and IDEs for clinical studies.
  • IVD-specific FDA requirements, including clinical validation, analytical performance, and Laboratory Developed Test (LDT) considerations.
  • Quality System Regulation (QSR) and compliance, including 21 CFR Part 820 requirements, differences from ISO 13485, and FDA inspections and enforcement.
  • Post-market requirements and FDA oversight, covering Medical Device Reporting (MDR), post-market surveillance (PMS), post-approval studies (PAS), recalls, corrections, and UDI obligations.
  • Regulatory submissions and interactions with the FDA, including preparing 510(k), PMA, De Novo submissions, pre-submission meetings, and understanding FDA market oversight.
  • Enforcement, compliance, and FDA audits, including inspection types, common findings, warning letters, Form 483 observations, and strategies to maintain compliance.
  • Practical considerations for FDA compliance, including best practices for submissions, common pitfalls, and case studies of regulatory challenges and resolutions. 

Flexible Online Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into navigating x.

Expert-Led Training for Practical Compliance

Meet the Trainer

Tim Joiner

Tim Joiner is a Senior Consultant with more than two decades of experience leading quality and regulatory strategies across the medical device and pharmaceutical sectors, specializing in quality management systems, global regulatory compliance, audit readiness, design control, and risk management.