Submissions and Approvals



The 21st Century Cures Act’s Impact on Medical Devices - Webinar CD/Transcript

The passage of the 21st Century Cures Act means you will be scrambling to meet new mandates… regulations and guidances in several key areas — including data development and maintenance, technical support, clinical approvals, breakthrough devices, device inspections and reviews, and humanitarian device exemptions. View

China Medical Device Regulatory Changes - Webinar CD/Transcript

If you’re doing business in China or want to — you need to know the latest device regulatory requirements for manufacturing devices there. This session will cover developments in manufacturing regulations including new GMPs, self-inspections, foreign inspections and trends in enforcement. View

New Trump Administration, New Republican Congress - Webinar CD/Transcript

The US has a new president, a new Congress, and almost assuredly a new agenda for the FDA — with different policies and priorities than the current administration. What does this mean for FDA regulated industries? View

Top Ten Data Integrity Traps: How to Find and Fix Problems

The Top Ten Data Integrity Traps report shows you where most data integrity problems occur and helps you create a plan to weed them out — and keep them out. View

How Does Cybersecurity Fit in Your QMS? - Webinar CD/Transcript

Learn the best practices for integrating medical security processes with the organization’s QMS and the ongoing role of Quality in securing connected medical devices. View

Conducting a Connected Medical Device Security Risk Assessment - Webinar CD/Transcript

How should you conduct a risk assessment for your connected medical devices? Security risk specialists Russel Jones and Nick Sikorksi — both with Deloitte & Touche — discuss how security risk assessments need to be conducted and how to develop remediations to reduce risks to an acceptable level. View

False Claims Act Liability for Regulatory Noncompliance - Webinar CD/Transcript

The Department of Justice’s interim final rule virtually doubles penalities for those that violate the False Claims Act. How can you avoid liability under the FCA? Join Anna Laakmann — Counsel, Greenberg Traurig — explains how regulatory noncompliance can form the basis of an FCA enforcement action by the government. View

Digital Innovation - Webinar CD/Transcript

It’s pretty clear that digital medical devices are transforming into information appliances connected to information systems, creating tons of new opportunities and even more challenges. Tim Gee — Principal and Founder of Medical Connectivity Consulting — provides insight into the regulatory landscape and recommendations for going forward. View

Training Staff to Detect Data Integrity Issues - Webinar CD/Transcript

Over the past few years, global regulators have increased their focus on data integrity systems. Who is responsible for data integrity? Find out in this 90-minute presentation. View

Devicemaker’s Guide to FDA Premarket Submissions

Determine the right pathway for FDA authorization of your new device. Order your Devicemaker's Guide to FDA Premarket Submissions 2 volume set. View

Spreadsheet Validation 2016 - Webinar CD/Transcript

What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View

Medical Device Inspections in China - Webinar CD/Transcript

If you’re doing business in China or want to — you need to know the latest device inspection requirements for manufacturing devices in China or importing them into the country. View