Simplifying Global Compliance
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EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
Editor's Picks
Bausch Hits Sandoz with Patent Suit over Xifaxan
Bausch asked the court to issue a permanent injunction against Sandoz’s generic until the patents expire.
Omega Medical Grabs FDA Clearance for AI Imaging System
The company claims that the device is the first of its kind in that it actually reduces radiation dose to patients and staff.
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How to Address Medical Device Sample Size Issues – Webinar Recording/ Transcript
$287.00
More 483s are being issued for violation of 21 CFR 820.200, statistical methods — most often for a lack of statistical justification for sampling plans. Design control statistical expert Steve Walfish is here to explain how to address your sample size issues. View
Develop World-Class SOPs that Minimize Human Error – Webinar Recording/Transcript
$287.00
Human Error Solutions’ CEO, Ginette Collazo, Ph.D. — an industrial-organizational psychologist and one of the world’s few human error reduction experts — will explain how to write and get SOPs that minimize human error. View
Medical Device Nonconforming Audit Findings – Webinar Recording/Transcript
$287.00
How should you respond to nonconformities from a notified body? Preparing your response can be daunting and can result in additional unnecessary efforts to your organization. View
Medical Device Warning Letters – Webinar Recording/Transcript
$287.00
Are you protected from the Forgotten Five most cited warning letter observations? If you’re not sure, you’re not alone. The Forgotten Five are not frequently discussed and have not generated much corrective information. In other words, the Forgotten Five are the highest-risk areas that offer you the most potential to prevent inspection issues. View
Transparency and the New Medical Device Reporting Rules – Webinar Recording/Transcript
$287.00
Do you have a handle on the changes you may have to make to your MDR program as a result of the Voluntary Malfunction Summary Reporting (VMSR) program? View
Using IT to Improve Data Integrity – Webinar Recording/Transcript
$287.00
Is IT a fully vested member of your data integrity team? The success of your next inspection could depend on it. But many firms — yours among them, perhaps — haven’t fully brought the IT folks onto the team. Now comes FDAnews with an all-new webinar to help solve this problem ... before the inspectors’ next visit. View
The AI Revolution – Webinar Recording/Transcript
$287.00
AI is changing the face of image analysis. How will the FDA keep pace with the evolving nature of these technologies while still ensuring that their safety and effectiveness are maintained? While there are still many issues the agency must work through, you need an understanding now of the FDA’s approaches to AI-based image analysis. View
Clarity on Clinical Investigations – Webinar Recording/Transcript
$287.00
The world of clinical investigations is changing rapidly, with the EU-MDR’s new and more complex system and the forthcoming ISO/DIS 14155:2018 updates. This presentation will provide insight into the EU-MDR’s extensive requirements for documenting, conducting and reporting clinical investigations, including which devices are exempt. View
Preparing for a MDSAP Audit – Webinar Recording/Transcript
$287.00
Devicemakers that export into Canada, Japan, Australia and Brazil face important changes to the audit and inspection process as the new Medical Device Single Audit Program (MSDAP) goes into effect. View
510(k) Change Analysis – Webinar Recording/Transcript
$287.00
The FDA’s 510(k) design change guidance documents are not the easiest to understand and incorporate. While the guidance’s flowcharts were designed to help guide evaluation and decision-making, they can instead be confusing. This presentation will provide you with a clear understanding of the decision paths and processes. View
Data Integrity – Webinar Recording/Transcript
$287.00
This presentation will explain high-level data integrity concepts, the definition and importance of data integrity, regulatory expectations for preventing data integrity issues, problem areas for data integrity and strategies for detecting potential data integrity issues in your operations. View
The EU-MDR Transition: Meeting the CE Mark Deadline
$397.00
The EU-MDR Transition: Meeting the CE Mark Deadline explains how to take advantage of the soft transition to the new regulation. The soft transition allows companies to retain certain aspects of the current CE Mark applications while following new registration requirements, if their notified bodies approve. View
