Research and Development

ARTICLES

FDA Seeks to Improve Medical Devices for Women

Improving analysis and data collection will require the development of common data elements for sex and gender to be included in some prominent medical device registries, said FDA Commissioner Scott Gottlieb.  Read More

PRODUCTS

The 510(k) Process - Webinar Recording/Transcript

$287.00
As medical device software and other technology continue to advance at a rapid pace, the FDA’s regulatory policies and processes are being forced to evolve to keep pace with innovation. View

Brexit and the Impact to Your Global Business Operations - Webinar Recording/Transcript

$287.00
Your international drug and device business is at a crossroads known as Brexit — the withdrawal of the United Kingdom (UK) from the European Union (EU). What can you expect? View

Device Software Development: A Guide to Risk Management Requirements

$397.00
Device Software Development — based on a presentation by quality systems expert Dan O’Leary — is a comprehensive, point-by-point guide to developing software that meets all FDA and international standards for successful market clearance. View

Understanding ISO 19011:2018 - Webinar Recording/Transcript

$287.00
The rules on device quality auditing are changing. There’s a new ISO 19011:2018 out with a new focus on risk management. View

De Novo Strategies for Getting Your Medical Device Approved - Webinar Recording/ Transcript

$287.00
Will de novo work for you? Don’t miss out on your chance to get a better insight into de novo’s requirements and timelines. View

Medical Device Software and Risk Management - Webinar Recording/Transcript

$287.00
It’s important for everyone involved in device design, cybersecurity and regulation to understand these issues. Dan O’Leary, simplifies the knotty area of FDA and international device regulation. View

Top Tips for Establishing Device Supplier Quality Metrics - Webinar Recording/Transcript

$287.00
You need to take your supplier quality metrics to the next level. The “Second Data Tier” — used in Compliance and Productivity Metrics — allows for stronger problem prevention and risk management of both internal and supplier processes. View

Corporate Compliance & Liability - Webinar Recording/Transcript

$287.00
It’s easy to lose sight of the big picture. But you do so at your peril. FDAnews has called on a top litigator with extensive criminal-law expertise, and a prosecutor too, for a rare learning session that steps back to focus on the big picture … then zooms in on details that can keep you out of trouble. View

Commissioner Gottlieb’s FDA: His First Year and a Look Ahead - Webinar Recording/Transcript

$287.00
What we know about the Gottlieb FDA: That lots is getting done. What we need to know: What will he do next? View

MDR Adverse Event Codes for Devicemakers - Webinar Recording/Transcript

$287.00
What devicemakers know is that MDR reporting is slated to change, with the old coding system going obsolete and new challenges arising to completion of Form 3500A. What many devicemakers still don’t know — but need to — is that the FDA is ready to assist you, with a free downloadable tool known as eSubmitter. View

Digital Health Tools: What YOU Need to Know - Webinar Recording/Transcript

$287.00
The FDA is moving fast into development of digital health tools. The moves promise competitive advantage to the drug, biologics, device and combo products makers who position themselves to take advantage … and new regulatory and compliance issues as well. View

Medical Devices and the FDA Reauthorization Act of 2017 - Webinar Recording/Transcript

$287.00
Many devicemakers are viewing changes in the FDA Reauthorization Act of 2017 (FDARA) as a good thing, but the devil is in the details — and some of those details start taking effect next month. It’s time you got up to speed. View