Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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FDA Advisory Committee Recommends Approval for Cannabis Derived Treatment for Epilepsy
The candidate’s PDUFA goal date is June 27, but an FDA representative said the agency is working to expedite the review.
Inspections and Audits
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Supplier Quality Metrics for Devicemakers: Predicting and Selecting the Best
$397.00
In the Supplier Quality Metrics for Devicemakers management report you’ll learn how to use predictive analysis of such metrics as delivery time, management efficiency and lot acceptance rate to identify suppliers you can count on and spot potential problems in the future. View
Top Tips for Dealing with the FDA - Webinar Recording/Transcript
$287.00
The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed. But you have a say in the matter. You can control this all-important relationship to your advantage. 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
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