Inspections and Audits

ARTICLES

Cirrus Healthcare Cited for Procedural Issues

The firm also failed to adequately maintain one of its device master records, as it was unable to provide the DMR specification for the chemical makeup of silicone material used in the firm’s ultra-soft silicone products. 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

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