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Simplifying Global Compliance
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GMP Inspection Preparation Checklist: A Tool for Internal Auditing
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Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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Inspections and Audits
ARTICLES
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
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
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
Surviving an MDSAP Inspection: A Guide for Devicemakers
$397.00
The prescriptive nature of the MDSAP model makes it relatively easy to prepare for an audit — if you know what to expect. Surviving an MDSAP Inspection provides all the information you’ll need to understand the MDSAP model. 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
Real World Evidence and the NEST Program: An FDA Perspective - Webinar Recording/Transcript
$287.00
The FDA is working with stakeholders across the medical device community to simplify the evaluation of new medical devices via Real World Evidence (RWE). A key component of that effort is the National Evaluation System for Health Technology, or NEST … and it could benefit you. View