Medical Devices Compliance Training

Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices - OnDemand Access

This OnDemand Web Seminar is also Available on CD

This medical device training will include a discussion on what constitutes valid scientific evidence to support advertising and promotional claims, a review of relevant Warning Letters to better understand FDA’s policies regarding comparisons to competitor products and what constitutes off-label use. Learn more

Post Market Surveillance in Today's Regulatory Environment - OnDemand Access

This OnDemand Web Seminar is also Available on CD

Since announcing its Postmarket Initiative in late 2006 the FDA is taking active steps to monitor pharmaceutical and medical device product problems is the field. FDA is no longer waiting until an inspection to discover potential problems with marketed devices but has established partnerships for data gathering from public and government sources. This means that medical device companies must increase their vigilance in gathering, analyzing and addressing problems with their devices in distribution. Learn more

Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs - CD

This OnDemand Web Seminar is also Available on CD

Why Should You Attend:

This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. Learn more

The Design and Management of Medical Device Clinical Trials: Strategies and Challenges

This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. Learn more

Encyclopedia of Medical Devices and Instrumentation, 6 Volume Set, 2nd Edition

The articles in The Encyclopedia of Medical Devices and Instrumentation focus on what is currently useful or is likely to be useful in future medicine. Learn more

The 510(k) Submission: Requirements, Contents, and Options CD

This 510 (k) training webinar will discuss the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Learn more

Practical Process Validations - Pack of Two Courses CD

Process validation is critical to the production of high quality, consistent, safe and effective products and devices. Routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of a product or device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated. Learn more

Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices CD

This OnDemand Web Seminar is also Available on CD

This medical device training will include a discussion on what constitutes valid scientific evidence to support advertising and promotional claims, a review of relevant Warning Letters to better understand FDA’s policies regarding comparisons to competitor products and what constitutes off-label use. Learn more

Bringing Compliance to Design Control for Older Products CD

This Medical device training will provide valuable assistance and give a procedure to all regulated companies that need to bring their product design history files up to date with the new standards. Learn more

Validation Planning to Meet US FDA and ISO 13485 Requirements CD

This FDA validation training will guide you through the validation planning which required meeting the US FDA & ISO 13485 Requirements Learn more

Pediatric Clinical Trial Design - Ethics, Management and Regulatory Requirements CD

This Pediatric Clinical Trial Design training explains the regulatory requirements for conducting clinical research in the pediatric population, the ethical considerations around the development of pediatric trials, and the challenges of research in this vulnerable population. Learn more

Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries

This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. Learn more

Design History Files and Technical Files under US FDA and EU MDD CD

This medical device compliance training will be helped to see how to understand the similarities and differences of these two complimentary documents and how to comply with the respective requirements and develop compliant files to address. Learn more

Software Verification and Validation For FDA-Regulated Industries CD

This FDA compliance training will guide you through Software Verification and Validation process in FDA-Regulated Industries. Learn more

New Medical Device Vigilance Guidelines CD

This Medical device training will provide valuable assistance and guidance to all medical device companies and user facilities involved in medical device vigilance Learn more

How to investigate environmental monitoring excursion limits CD

Medical products are manufactured in environments that are designed to control the level of viable and non-viable particulate and these environments must be monitored to establish that the control measures are continuing to perform acceptably including the impact to product bioburden. You need to establish appropriate limits for ongoing monitoring so it is critical that you know how to set these limits. But once these limits have been set it is also critical for you to know what actions need to be taken to determine if there is product impact or other implications to the manufacturing process when the monitoring results exceed these defined limits. Learn more