The Basis of EU IVD Regulations- Learning Outcomes

European Medical Device Regulations - IVDD to IVDR

Main Requirements for IVDR Compliance

Rules for Classifying the In-Vitro Diagnostic Devices

Risk Management and Labeling Requirements of IVDR

The Basis of EU IVD Regulations- Lesson Summary

This module explains the EU IVDR, a regulation imposed across the European Union to govern the major aspects of the manufacturing and import of in-vitro diagnostic devices. You will mainly learn about their classification, labeling, and compliance requirements. You will also learn about the rules used to categorize these devices.

Fundamentals of EU IVDR Regulations for In-Vitro Medical Devices - Assessment

Learn the basic rules and principles of the EU In-Vitro Diagnostic Device Regulation in this free online course.

Fundamentals of EU IVDR Regulations for In-Vitro Medical Devices

EU IVDR (in-vitro Diagnostic Device Regulation) has been successfully implemented across the European Union. It contains a lot of new requirements and conditions with which manufacturers should comply. In this course, we have included the material that will enable you to help manufacturers achieve the required compliance. This course will teach you about all the essential rules, requirements, and device classifications.

Learning Outcomes

Overview of the Federal Food, Drug, and Cosmetic Act (FDCA)

Federal Food, Drug, and Cosmetic Act: Scope, Impact, and Amendments

FDA Regulations and Key Provisions

Oversight and Its Impact on Cosmetics and Public Health

Lesson Summary

This module provides essential training on understanding and complying with the Federal Food, Drug, and Cosmetic Act (FD&C Act). It covers key aspects such as the historical context and significance of the Act, the roles and responsibilities of regulated entities, the process for ensuring compliance, and the implications of non-compliance.

Fundamentals of Federal Food, Drug, and Cosmetic Act (FD&C Act) - Course Assessment

This free online course teaches you how to navigate with the FD&C Act to ensure product safety and compliance.

Fundamentals of Federal Food, Drug, and Cosmetic Act (FD&C Act)

Complying with the Federal Food, Drug, and Cosmetic Act ensures safety by following standards for product quality, labeling, and reporting. Key aspects include accurate record-keeping, good manufacturing practices, and proper testing. Regularly reviewing and updating compliance procedures based on regulatory changes and feedback enhances product safety and legal adherence, protecting consumers and maintaining industry standards.

Steps in Medical Device Marketing

FDA Marketing Pathways for Medical Devices

ISO 13485 vs 21 CFR Part 820

This module teaches you about the basic steps of medical device marketing within the US regulatory environment. You will also learn about the marketing pathways as defined by the US FDA and the premarket requirements before submission. The module also highlights the major differences between ISO 13485 and 21 CFR Part 820.

Fundamentals of US FDA Medical Device Submission Process - Course Assessment

This free online course takes you to the path of medical device marketing in compliance with the US FDA regulations.

Fundamentals of US FDA Medical Device Submission Process

The US FDA has enacted several regulations and policies for medical device manufacturers who wish to market their medical devices in the USA. Enrolling in this online course will familiarize you with the basics of this regulation and help you understand different marketing pathways. You will also get a brief orientation of ISO 13485 and 21 CFR Part 820, the standards required to establish a QMS in the medical device manufacturing industry.

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