Design Controls for the Medical Device Industry
Available
Provides a blueprint to create an effective design control program.

Reliable Design of Medical Devices
Available
The benchmark for incorporating reliability engineering as a fundamental design philosophy.

Promotion of Biomedical Products: Regulatory Considerations
Available
Examines advertising, labeling and promotion regulations.

Validation Standard Operating Procedures: 2nd Edition
Available
Researches achieving compliance with FDA’s GMPs, GLPs and validation requirements.

Medical Devices: Definition & Lifecycle
Available
This course provides a basic introduction to medical devices, general aspects of product and regulatory lifecycles, a brief history of medical device regulation and information on basic regulatory principles and concepts as they apply to medical devices.

Regulation of Combination Products
Available
This course examines the current regulations and policies covering the identification, jurisdiction and review of combination products in the US. It covers premarket activities, applicability of Good Manufacturing Practice (GMP) and postmarket requirements, such as adverse event reporting, inspection and enforcement.

Medical Devices: Canadian Regulations
Available

This course covers a wide range of issues from the regulatory framework provided by Health Canada, through the steps to submit an investigational testing application or a medical device licence application, to postmarketing activities. It will discuss classification of devices, selection of the appropriate license type, submission requirements, quality systems and postmarketing requirements.

Global Regulatory Strategy for Medical Devices
Available
This course provides a basic description of global regulatory strategy and offers guidelines for developing successful global strategiesfor medical devices.

Medical Device: EU Regulations
Available
This course follows the regulatory requirements through the lifecycle of the product, providing a strong foundation of the key elements of the EU directive requirements, including the AIMDD,  MDD and IVDD. You will examine how devices are classified and how this classification affects the labeling, registration, marketing and postmarketing requirements.

Regulation of IVDs
Available

This course provides an overview of IVDs worldwide with focus on the US FDA. It introduces key regulations and guidelines necessary for effective product development and explains the history of IVDs, development and testing, getting a product to market, product review, submission and harmonization.