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Medical Device Trials in the EU: A Guide to the New EU MDR and Revised ISO 14155

March 9, 2020
This management report provides insight into the EU MDR’s extensive requirements for documenting, conducting and reporting clinical trials, including which devices are exempt. Manufacturers of non-exempt devices must set up a clinical trials program using both EU MDR and ISO/DIS 14155:2018.

Clinical Trials Adverse Event Reporting Guide - 2020 Edition

March 9, 2020
The Clinical Trials Adverse Event Reporting Guide covers more than 20 guidances from the FDA, HHS and the ICH and includes the text of all regulations pertaining to reporting adverse events in clinical trials.

Managing Data and Documentation for FDA Inspections - 2019

February 5, 2020
Is your company’s data and documentation organized and ready for your next FDA inspection? This management report will help you get control of your data by using industry best practices and SOPs.

Design Change Analysis: Five Steps to Compliance

January 30, 2020
This management report explains the design change procedure required by the FDA, including five steps that most devicemakers don’t realize are necessary until an FDA inspection points out the gap in a company’s procedures and documents.
Writing SOPs: Best Practices for Life Sciences Companies

Writing SOPs: Best Practices for Life Sciences Companies

December 9, 2019
Your standard operating procedures are one of the first things FDA investigators will look at during an inspection. Yet, "inadequate SOPs" rank among the most-frequently cited Form 483 observations. This new management report will teach you the practical techniques you need for crafting well-written, fast-read, flexible and compliant SOPs - SOPs that will meet FDA requirements as well as today's globalized expectations.
Using ISO 11607 to Develop Risk-Based Device Packaging

Using ISO 11607 to Develop Risk-Based Device Packaging

December 9, 2019
Using case studies and other frontline knowledge this report will show you how to leverage a risk-based packaging approach to prevent nasty audits and recalls ... without busting a hole in your compliance budget. With it, you'll get step-by-step guidance through the bewildering FDA packaging requirements, beginning with a discussion of how and why packaging is causing significant harm to devicemakers. You'll also learn why your packaging might be at risk - and what you must do to reduce field complaints, recalls or FDA enforcement actions.
Using Social Media in Clinical Trial Recruitment

Using Social Media in Clinical Trial Recruitment

December 9, 2019
Today, one in five sponsors uses social media to engage, recruit, and retain subjects for clinical trials. And why not? Clearly, social media is increasingly where your prospective study subjects are going to be found. This report is designed to help unsure clinical trial recruiters put aside their concerns and go ahead with social media recruiting of trial subjects. And if you're already using social media, it's an opportunity to hear how other organizations are overcoming challenges and employing social media for increasingly successful recruitment.
Using the MDSAP Model to Win International Device Approval

Using the MDSAP Model to Win International Device Approval

December 9, 2019
This management report explains what MDSAP auditors will focus on and teaches you how to build an internal audit program that will get your quality system in state-of-the-art shape for international inspections.
Winning Device EU Marketing Approval: Seven Steps to Writing Clinical Evaluation Reports

Winning Device EU Marketing Approval: Seven Steps to Writing Clinical Evaluation Reports

December 9, 2019
If you want to market your device in Europe, you need to provide clinical evidence that the product is safe and effective. But if your development phase didnt include clinical trials, how can you make that argument? This FDAnews Brief walks you through the process of developing and writing a CER with a 7-point model that ensures you cover all the bases and have the greatest chance of success.
Understanding the New EU Medical Device Regulations

Understanding the New EU Medical Device Regulations

December 9, 2019
The EU has just made sweeping changes to its medical device regulations (MDR) — replacing the three current guidance directives with two massive regulations binding manufacturers to a variety of new requirements. This management report directs you through the new MDR and in vitro diagnostic device regulations (IVDR) and explains the impact on the development, marketing and monitoring of your devices.
Top Trends in Drug and Device Advertising and Promotion: Enforcement Priorities for the FDA and FTC

Top Trends in Drug and Device Advertising and Promotion: Enforcement Priorities for the FDA and FTC

December 9, 2019
Drug and device advertising, marketing and promotion are edging into some brave new worlds. Its not OK for creative teams to operate unaware of FDA and FTC rules and attitudes. This report takes a deep dive into six areas regulators give the most attention.
Troubleshooting Your Quality System: A Guide to Five Devicemaker Quality Compliance Traps

Troubleshooting Your Quality System: A Guide to Five Devicemaker Quality Compliance Traps

December 9, 2019
Medical device manufacturers often dread the FDA inspector's arrival. But here's a shortcut to success you can master in an hour or so. There is a little-known secret: Five problem areas account for one-fourth of all Form 483 observations the FDA issues devicemakers in a given year. Master these and you've taken a giant step toward inspection success. And now, FDAnews has created a management report focusing on just those five areas.

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