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The FDA Under a New Commissioner - Webinar CD/Transcript

$287.00
Likely new FDA Commissioner Scott Gottlieb is an old agency hand thrust into a new role. Will he toe the Trump line ... or show independence? Is his past a guide ... or will he strike out in new directions? Will he ease new drug and device approvals ... or toughen them? Increase inspections ... or ease off? More 483s and warning letters ... or fewer? View

Nine-Volume Title 21 CFR Set 2017

$585.00
The federal government has compiled the new 2017 CFR volumes.






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Detecting Trends in Medical Device Complaints - Webinar CD/Transcript

$287.00
When device users complain, those complaints must be passed on – to the FDA, the EU and other regulators. The FDA’s QSR. International standards ISO 13485:2003 and ISO 13485:2016 ... The EU Vigilance system and the draft EU Medical Device Directive (MDR) ... Couldn’t you use help with your complaint reporting systems? View

Seven Steps to Successful Medical Device Reimbursement

$397.00
Order Seven Steps to Successful Medical Device Reimbursement for an overview of the regulatory and reimbursement processes and how they fit together. View

Industry Trends and Best Practices for the Cleanroom Environment - Webinar CD/Transcript

$287.00
Cleanrooms are complicated. Product selection, rotating disinfectants, applying disinfectants and controlling bioburdens and residues are all part of the job. But what is the best way to handle it all? View

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 - Webinar CD/Transcript

$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