Postmarket Safety

ARTICLES

PRODUCTS

FDA’s NEST Program and Real World Evidence - Webinar Recording/Transcript

$287.00
The FDA is working on simplifying the evaluation of new medical devices via Real World Evidence (RWE). The FDA initiative is known as NEST (National Evaluation System for Health Technology) … and it could benefit you. View

Nine-Volume Title 21 CFR Set 2018

$585.00
The federal government has compiled the new 2018 CFR volumes.






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Investigations Operations Manual 2018

$377.00
Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility. Get a heads up with Investigations Operations Manual 2018. View

Advertising & Promotion Hot Topics in Today’s FDA and FTC Landscape - Webinar Recording/ Transcript

$287.00
Drug and device advertising, marketing and promotion has come a long way from 30-second TV spots. These days the cutting edge is social media, product placement, engaging influencers, reality TV, pop-up shops and more. View

Meeting the Competence, Training and Awareness Rules for Medical Device Manufacturers - Webinar Recording/Transcript

$287.00
Device manufacture is a complicated business, but few areas are more rulebound than QMS. Many a devicemaker has come up short trying to stay abreast of the FDA’s QSR, ISO 13485:2016, and other ISOs while trying to comply with competence, training and awareness rules. View

CDRH Reorganized: New Strategies for Devicemakers

$397.00
CDRH Reorganized lays out all of the moving pieces and lets you know what to expect, how to take advantage of new opportunities and how to influence the direction of the new system. And you’ll hear it from one of the people most qualified to interpret the changes, former CDRH Associate Director of Policy Paul Gadiock. View

Setting and Measuring Quality Objectives for Medical Devices - Webinar Recording/Transcript

$287.00
Device quality must be implemented and communicated to the FDA, on pain of warning letters or worse. The rules and procedures are technical, involving both FDA rules and ISO 13485:2016. But mastery can be accomplished in only 90 minute View

Managing Cybersecurity Risks in the Medical Device and Healthcare Sectors - Webinar Recording/Transcript

$287.00
“Smart” medical devices offer juicy targets to mischief-makers, and the threat is a global one. From garden-variety hackers, to cyber-mercenaries, to nation-states bent on global chaos, devicemakers face uncharted regulatory and liability risks. View

New Direct Marking Requirements for UDIs - Webinar Recording/Transcript

$287.00
The FDA’s final guidance on UDI (unique device identification) raises as many questions as it answers. With full compliance for Class I, II and unclassified devices looming, lawyers are hard at work parsing the FDA’s language. View

Supplier Quality Metrics and Scorecards - Webinar Recording/Transcript

$287.00
The device supply chain can include hundreds of companies and stretch around the globe. Maintaining quality is a herculean task, yet the FDA requires it of you — at the risk of Forms 483, warning letters or worse. View

European Medical Device Regulations (EU MDR) - Webinar Recording/Transcript

$287.00
Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations. View

The CDRH Reorganization - Webinar Recording/Transcript

$287.00
Device regulation is about to change in ways large and small, as the CDRH moves toward a total reorganization. After it’s complete, the principal medical device overseer is expected to take a total product life-cycle (TPLC) approach, whereby postmarket realizations are fed back into premarket data requirements. View