Research and Development

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Biocompatibility for Medical Devices - Webinar CD/Transcript

$287.00
Translating government gobbledygook into English is no small task. And the FDA isn’t the only regulator to worry about. Misinterpret a few words of the EU regs and see how much trouble you’ll land in. View

Devicemaker’s Guide to the 21st Century Cures Act: Changing the Face of Medical Device Regulation

$397.00
Devicemaker’s Guide to the 21st Century Cures Act tells you what to expect in the coming months, which new provisions are likely to cause trouble and how to get out in front of the changes. View

Navigating China’s Medical Device Regulations

$397.00
Navigating China’s Medical Device Regulations brings you up to date, explaining how the Chinese system and culture work, what the regulatory changes are, how to react to new requirements and what may come in the future. View

Device Accessories – Understanding and Implementing the Final Guidance

$287.00
On Dec. 30, 2016, the FDA-CDRH+CBER issued a final guidance document to describe accessories and — in certain cases — provide a classification pathway. Dan O’Leary explains the approach in the guidance document and gives you the tools you need to determine and document whether any of your products are an accessory. View

FDA’s Guidance on Postmarket Management of Cybersecurity in Medical Devices - Webinar CD/Transcript

$287.00
How can you protect your medical devices from ever-changing cybersecurity threats? Join Nick Sikorski and Robert Mai — both of Deloitte & Touche LLP – Cyber Risk Services — for a discussion on the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016. View

Combination Products and Cross-Center Reviews - Webinar CD/Transcript

$287.00
Mapping out a regulatory pathway for drug/device/biologic combination products remains one of the most difficult regulatory challenges for life sciences innovators. Join David M. Fox — Partner, Hogan Lovells — for a close look at the FDA’s new authority governing combination products and several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. View

Five Case Studies Using the E2500 Approach to Validate Equipment, … - Webinar CD/Transcript

$287.00
The E2500 approach streamlines design qualification by focusing on design and verification of critical aspects of a manufacturing system that affect product quality and patient safety. Implementation is not easy, but worthwhile. Once implemented E2500 can effectively reduce the testing, staffing, costs and time associated with the design-qualification phase of a system’s lifecycle. View

The 21st Century Cures Act & Regenerative Medicine - Webinar CD/Transcript

$287.00
The biologics license application (BLA) is perhaps the most burdensome and lengthy premarket review process that the FDA imposes. To address that, Congress created the Regenerative Advanced Therapy (RAT) designation. View

How to Integrate FDA Device Approval and Reimbursement - Webinar CD/Transcript

$287.00
Join Steve Terman — Principal Attorney, Olson Frank Weeda Terman Matz — and Gordon Schatz — President, Schatz Reimbursement Strategies — as they explain how to strategically blend reimbursement with FDA regulatory issues and identify the need for outcomes data, comparative evidence, professional society guidelines and how to meet Medicare and managed care reimbursement standards. View

New Medical Device and In Vitro Diagnostic Regulation in the EU - Webinar CD/Transcript

$287.00
Join Michael M. Gaba — Life Science Partner, Holland & Knight LLP, USA — and Shayesteh Fürst-Ladani — founder and CEO, SFL Regulatory Affairs & Scientific Communication Ltd., Switzerland — for a discussion on the biggest anticipated changes to the EU and U.S. medical device framework and their impact on global go to market strategies, including the extent to which a company can harmonize its regulatory effort for the global market. View

Corrective Action & Preventive Action for Medical Devices - Webinar CD/Transcript

$287.00
Join industry expert Dan O’Leary as he identifies the most frequently cited steps in the corrective and preventive action processes, explains the issues that warning letters reveal and provides information to avoid these problems. View

Clinical Trial Compliance Guide: FDA Requirements

$397.00
The FDA has issued more than 100 guidance documents relating to clinical trials covering topics from the Animal Rule to validating software used in studies. If you had to pull all of them together yourself — and get the right version — it would take you hours. View