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Dealing with Chinese Medical Device Regulatory Authorities - Webinar CD/Transcript

$287.00
To American eyes, the Chinese regulatory system is ... well, a Chinese puzzle. You can’t hope to get a registration approved without a knowledgeable and trustworthy local guide. Face it: You need expert help. And we’ve got just the expert to help you. View

Medical Device Clinical Evaluation Reports - Webinar CD/Transcript

$287.00
Michelle McDonough — Associate Director, Regulatory and Clinical Affairs, MCRA — discusses the requirements for CERs and their place in supporting new device certification and maintaining certification. She will cover best practices for completing CERs, complying with regulations including the MEDDEV 27/1 Rev 4 guidance. 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

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

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

The Reality of Doing Business in Cuba in 2017 - Webinar CD/Transcript

$287.00
Join Jennifer Diaz — a board certified international attorney — as she discusses the realities of doing business in Cuba including whether the new Trump administration will continue with efforts to open up Cuba to U.S. business or if we will see a return to the more closed and distant relationship of the past. View

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

$287.00
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

$287.00
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