Medical Device Regulatory Compliance Training - Live Webinars, Recordings & CDs

This 6-hr training provides a detailed understanding of process validation for medical devices approach employing IQ, OQ, and PQ. Information includes preparation of protocols and reports, application of Statistical Process Control, concepts of Design of Experiments, using attribute sampling plans, and a discussion of GHTF document on process validation.

This 90-minute 510(K) training will provide practical tips and tools (templates) for preparing regulatory marketing submissions that will ensure swift clearance of your Class II and Class III medical devices.

This Software Verification and Validation training will help you understand and recognize the most common software V&V failings and their fixes. You will learn how to develop and use a repeatable software V&V template for all software validation projects.

This 90-minute webinar will help you understand the current landscape of the growing field of mobile medical applications and the current regulatory efforts to ensure that the related medical devices will not pose high risks for patient safety and promote innovations.

This 120-minute webinar will help medical device manufacturers to understand what you need to do to ensure that your process, the methods, and the procedures that you have established to implement the requirements for design controls are in perfect order.

This webinar will provide processes and procedures to all medical device companies that are thinking of transferring equipment, molds, dies, systems and processes to contract manufacturers. It will follow a recent successful case study in the medical industry.

This 120-minute webinar will cover best practices and standardized processes, outlined in ISO 14971, for managing risk in medical devices. You will learn from the shared experience and examples provided by the speakers on how to implement proper and effective risk management processes and practices at your company.

This 90-minute webinar will help you understand the competence and training requirements in the Quality Management Systems for medical devices, especially FDA QSR, ISO 13485, and even ISO 9001.

This 90-minute webinar will cover the best industry practices for Failure Modes and Effects Analysis (FMEA). You will learn what mistakes to avoid, how to reduce design and manufacturing defects, and how to implement risk management efficiently.

This 90-minute webinar will discuss the current good manufacturing practices (cGMPs) for medical devices and in vitro diagnostic devices.

This 90-minute webinar on sampling plans using ANSI/ASQ Z1.9 will explain the methods in Z1.9 and shows how to use it in a more modern setting (using simple statistical calculators).

This 90-minute presentation will discuss a structured way to mitigate risks with minimum cost. You will learn how to use FMEA to effectively estimate and assess risks in your medical device.

This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software.

This 90-minute webinar on device corrections and removals will clarify your obligations for corrections and removals under Part 806 of the FDA regulations.

This 3-hr virtual seminar will provide an introduction to FDA’s Regulation of Medical Devices and is intended for the Beginner. It will cover device classification, the device manufacturer’s and/or distributor’s regulatory responsibilities, requirements for labeling and user fees, fda inspections and enforcement.

This webinar explains the application of Risk Management for medical devices using ISO 14971:2007. It explains the flow of information from the Risk Management Plan to the Risk Management Report, looking at important terms including Hazard, Harm, and Risk and explaining how to use each one. The program describes development of a Risk Evaluation form that implements the requirements of ISO 14971.

This 3-hr virtual seminar will discuss the requirements and compliance in medical device adverse event reporting and medical device surveillance/vigilance system in the US, Europe and Canada. It is designed to help the audience with their global compliance in adverse event reporting and surveillance/vigilance system during pre- and post-marketing.

This 90-minute webinar will help you understand the 510K process including some history about 510ks versus PMAs and give you the necessary information to know when to file a 510k, as opposed to a PMA, or to not file any 510K of a new or existing medical device.

This webinar will cover the basics of design controls for medical devices, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well.

This 3-hr training will discuss medical device regulations and law in the US, Europe and Canada. It is designed to help the audience with their global compliance and regulatory intelligence, which is necessary to streamline the regulatory process in an organization to achieve sustainability and to remain sustainable and competitive in global markets. This seminar is a “How To Guide” intended to streamline the decision-making process in a systematic manner.