Medical Device Documentation and Data Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

This session will discuss in detail the Final Rule for the Physician Payment Sunshine Act, its impact and how to prepare for it. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS.

This training on Asian medical device regulations will discuss the regulatory framework for medical devices in China, Hong Kong, Japan and Korea. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these Asian countries.

This training will outline the best practices in responding to a FDA Warning Letter so the consequences of the findings do not escalate beyond the current status.

This ISO 13485 requirements training will provide guidance to medical device companies in developing an adequate Quality Management System (QMS) in accordance with ISO 13485 and FDA expectations. This webinar will also benefit medical device companies that are planning to market their products in Europe.

This medical device 510(k) training will explain the basics of 510(k) submissions and discuss tips, strategies and tools to develop and execute an approval strategy ensuring the fastest possible path to market.

This webinar will familiarize you with FDA requirements for electronic and digital signatures, and the agency's inspection and enforcement practices. Particpants will recieve complimentary hand-outs for easy implementation.

This 90-minute webinar will explain FDA's 1997 guidance on 510(K) for device modifications and show how to integrate the evaluation into your design change program. The webinar uses numerous Warning Letters to illustrate the points, and helps you learn from others.

This EU MDD webinar will help you understand and recognize the most significant changes proposed for the new European Medical Device Regulations: 2012/0266 (COD). You will learn which procedural changes your company should be making now so that you stay in compliance throughout the transition period and reduce potential delays to new product introductions in the EU market.

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 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 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 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 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 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.

This FDA Good Documentation Practices training will introduce and explain the concept of Good Documentation Practices, and provide real-world examples of how to, and how not to, use GDPs.

This training will outline practical steps to design medical device software that does not compromise on performance reliability and patient safety, thereby preventing product recalls.

This training on auditing of software vendors for FDA compliance will explain the types of audit and its use in qualifying and selecting vendors. It will discuss sample forms and checklists which may be used by the participants for observations, recommendations and remediation.