Postmarket Safety

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

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

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

Nine-Volume Title 21 CFR Set 2019

$585.00
The federal government has compiled the new 2019 CFR volumes.






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Wearables and Sensors – Webinar Recording/Transcript

$287.00
The rapidly evolving landscape for wearables and sensors is having a mighty impact. Former FDA staff member Sugato De, MS — Vice President, Parexel International — and regulatory expert Peter Steiger — Vice President, Parexel Informatics — will explain what you need to know and share management strategies to make it all work for your organization 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

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

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