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.
Editor's Picks
Reva Medical’s Fantom Encore Receives CE Mark
The expanded approval covers the Fantom Encore in 3.0 and 3.5 mm diameters.
FDA Seeks Comments on Technical Standards for Electronic Submissions
The agency wants to hear from stakeholders about “the use of technical specifications guidances and the data standards they contain.”
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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
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
Inside FDA’s Oncology Center of Excellence - Webinar Recording/Transcript
$287.00
Cancer therapies have a new friend at the FDA. The year-old Oncology Center of Excellence is tasked with expediting development of oncology and hematology medical products — drugs, biologics and devices — and supporting an integrated approach to clinical evaluation of cancer treatments. 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
UDI Direct Marking for FDA Compliance: Navigating New Rules
$197.00
Jay Crowley was the architect of UDI while at the FDA. Now a consultant advising devicemakers, he remains the go-to expert on UDI compliance. In the FDAnewsBrief, UDI Direct Marking for FDA Compliance, Crowley lays out a path to compliance. 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
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
EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
$397.00
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing. View
Advertising & Promotion - Webinar Recording/Transcript
$287.00
Drug and device makers must advertise to survive, but the legal issues surrounding advertising and promotion are far from settled. FDA enforcement actions don’t seem to show a consistent pattern, leaving you to guess whether a warning letter lurks ahead and how to avoid it. 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