Postmarket Safety

ARTICLES

TGA Logs More Adverse Event Reports for Devices

Australia’s Therapeutic Goods Administration saw a significant increase in adverse event reports for medical devices in 2016 — logging 3,841 AERs compared with 3,359 the previous year — according to the latest data from the agency. Read More

PRODUCTS

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

Lean Management to Improve Quality & Compliance - Webinar CD/Transcript

$287.00
“Lean management” has come to the drug and device world, improving quality, ensuring compliance and boosting profits for those who adapt its ways to the production floor. If you’re not among them yet, then listen up. View

Medical Device Calibration Program - Webinar Recording/Transcript

$287.00
Devicemakers: The quality of your manufacturing is only as good as the quality of your measuring equipment. But you can spend a fortune on metering devices and still turn out shoddy products. It all depends on how well they’re calibrated. View

Sensors and Wearables in Clinical Trials - Webinar Recording/Transcript

$287.00
There’s a transformation going on in the clinical trials world. It’s called mobile health (“mHealth”), and it entails use of smartphones, sensors and wearables to monitor trial subjects in ways not previously possible. View

510(k) Change Analysis - Webinar Recording/Transcript

$287.00
On Nov. 8, the FDA is expected to issue twin final guidances revamping the device change process and determining when a new 510(k) is required. We explain it all to you ... and outfit you with tools to comply. View

The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium

$397.00
The 21st Century Take on Observational Studies walks you through everything you need to know about the opportunities and pitfalls observational studies can offer. The report looks at the growing trend toward observational research and how provisions in the 21st Century Cures Act create even more incentives to rely on real-world evidence in the development of medical products. View

Must-Know Contracting for Non-Lawyers - Webinar Recording/Transcript

$287.00
When it comes to supply contracts, it’s far better to do things right going in ... rather than pay the price down the road. In just 90 fast-moving minutes, Courtney Young Esq. of MedMarc Insurance Group walks you through the essentials of supply contracts — what to include, what to (safely) leave out, how to stand up for yourself. View