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

This training program on lean documents will present a fresh departure from general practices, while building upon proven principles. The theory of lean documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and push systems, many traditional document practices are artifacts of a flawed approach. This webinar will highlight how lean configuration comes from the same principles, and utilizes the unique power of software solutions to take over functions that had previously burdened controlled paper documents.

This FDA guidance training on RUO (Research Use Only) and IUO (Investigational Use Only) products will enumerate FDA requirements for research use only and investigational use only IVD products. The webinar instructor, an industry expert, will highlight appropriate labeling and distribution practices for RUO and IUO products and detail instructions for use of an IVD product labeled RUO or IUO.

This webinar will highlight the distinctions between ISO 13485 and FDA’s QSR. It will further introduce attendees to key clauses and requirements pertaining to the two regulations and also detail internal audit requirements.

This FDA compliance webinar will discuss in detail the guidance on recognition and use of consensus standards. It will focus on the topics such as voluntary conformance, declaration review and content of declaration of conformity.

This webinar will provide the typical elements required to be included in the Batch Production Record and the Device History Record in order to accomplish a quality and cost effective review and quality assessment based on current regulatory expectations.

The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process. Most medical device manufacturers use FMEA as a part of their risk management system. Most medical device manufacturers use FMEA as a part of their risk management system.

This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.

This training on FDA regulation of mobile medical applications is designed to provide attendees with an overview of the U.S. Food and Drug Administration's oversight of certain medical and healthcare mobile medical applications ("apps") designed for use on smartphones and other mobile computing devices. Attendees will learn to distinguish between those apps requiring FDA review and those not subject to regulatory oversight.

This webinar on Design History Files (DHF) will provide a step-by-step procedure for all medical device companies that are considering the need to bring their product design history files up to date with the current standards.

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 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 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 6-hr webinar on Reliability Engineering Fundamentals for Medical Devices will cover the science and techniques for designing highly reliable medical devices at lower cost and in lesser time.

This 4 hour training will focus on best practices in design reviews and show how you can add high value to your products and processes by improving the performance while reducing the life cycle costs significantly.

This Product risk management training/webinar for Medical devices will help in to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007. The US FDA is increasingly stating that many regulated activities should be “risk-based”. Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach. This eliminates the current SOP-defined “one size fits all” approach, to a flexible, resource adjusted approach, less arbitrarily defined in an SOP, but yielding results targeted to real needs. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry. Then how to use this document to accomplish the above goals.

This webinar will provide valuable assistance and guidance for medical device companies to ensure they have a well defined, deployed and enforceable design validation program. Did I make the right product and can I prove it is Design Validation! Device manufacturers need to establish and maintain procedures for validating the device design. Design validation has to be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation must ensure that the company’s device or devices conform to defined user needs and intended uses and will include testing of production units under actual or simulated use conditions.

This Risk management training will guide you through how to integrate the elements of ISO14971 (Risk management for medical devices) in your design process.

This Life cycle management training will provide valuable assistance and gives a process to product design history files and technical files up to date with the new standards through life cycle management.

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device.

Detailed analyses of the sections of the QSR design control regulations that have requirements not present in the ISO 13485:2003 standard. Many companies are confidant that their ISO 13485:2003 design control system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 design control cites are written and warning Letters, seizures or worse ensue.