Simplifying Global Compliance
Recommended Products
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
Lax Quality Observed at Device Facility in China
The company failed to investigate a customer complaint about a malfunctioning device.
Three Breast Cancer Drugs Pose Risks of Lung Inflammation, FDA Says
Possible symptoms include shortness of breath while resting or during low physical activity, the agency said.
Inspections and Audits
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ARTICLES
PRODUCTS
Medical Product Off-Label Use and Marketing – Webinar Recording/Transcript
$287.00
Mark Levy, Esq. — a litigator and trial attorney who is an expert in defending companies in alleged criminal and civil violations of the False Claims Act and the Food, Drug and Cosmetic Act — is here to share his knowledge of compliance regarding off-label marketing with you. 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
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
Cybersecurity & Privacy Risks for Medical Device Companies – Webinar Recording/Transcript
$287.00
Cybersecurity issues are public health issues: Are your devices and processes at risk? View
Animal Tissue Use in Medical Devices – Webinar Recording/Transcript
$287.00
Implementing compliant systems for medical devices with animal tissue requires multiple control layers, typically using standards in the ISO 22442 family — some of which are under revision. View
European Medical Device Regulations (EU MDR) - Webinar Recording/Transcript
$287.00
Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations. View
Organizing Data and Document Archives - Webinar Recording/Transcript
$487.00
Are your documents as organized as you think they are? Can you easily put your hands on the documents FDA investigators request? Or are you searching for that needle in a haystack? View
