QSR

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Digital Health Tools: What YOU Need to Know - Webinar Recording/Transcript

$287.00
The FDA is moving fast into development of digital health tools. The moves promise competitive advantage to the drug, biologics, device and combo products makers who position themselves to take advantage … and new regulatory and compliance issues as well. View

Medical Devices and the FDA Reauthorization Act of 2017 - Webinar Recording/Transcript

$287.00
Many devicemakers are viewing changes in the FDA Reauthorization Act of 2017 (FDARA) as a good thing, but the devil is in the details — and some of those details start taking effect next month. It’s time you got up to speed. View

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

FDA and ISO Devicemaker Training Requirements

$397.00
FDA and ISO Devicemaker Training Requirements breaks down training requirements in both the FDA’s QSR and international standards ISO 13485, 9001 and 10018 — among others — shows where they overlap and where they differ and provides a plan for developing a training program that fills in all the gaps. View

Preparing for the MDSAP Audit Process - Webinar Recording/Transcript

$287.00
Devicemakers that export into Canada, Japan, Australia and Brazil face important changes to the audit and inspection process as the new Medical Device Single Audit Program (MSDAP) goes into effect. View

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

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

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

Medical Device Calibration: A Step-by-Step Guide to Meeting FDA and ISO Standards

$197.00
Medical Device Calibration: A Step-by-Step Guide to Meeting FDA and ISO Standards provides a roadmap that walks devicemakers through each aspect of calibration requirements — showing where the FDA and ISO differ and where they match up — and explains how to combine them to endure full compliance. 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

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