Simplifying Global Compliance
Recommended Products
EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
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.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
Editor's Picks
European Commission Clears Up Devicemaker Vigilance Obligations
The guidance includes an updated manufacturer incident report (MIR) form that will be required for devices certified under MDD in January 2020.
Spanish Regulator Cites Drugmaker for Quality Fraud
The firm had stopped recording deviations and out-of-specification results for various drug products since January.
Postmarket Safety
RSS
ARTICLES
PRODUCTS
Wearables and Sensors – Webinar Recording/Transcript
$287.00
The rapidly evolving landscape for wearables and sensors is having a mighty impact. Former FDA staff member Sugato De, MS — Vice President, Parexel International — and regulatory expert Peter Steiger — Vice President, Parexel Informatics — will explain what you need to know and share management strategies to make it all work for your organization View
Cybersecurity & Privacy Risks for Medical Device Companies – Webinar Recording/Transcript
$287.00
Cybersecurity issues are public health issues: Are your devices and processes at risk? View
The EU-MDR Transition: Meeting the CE Mark Deadline
$397.00
The EU-MDR Transition: Meeting the CE Mark Deadline explains how to take advantage of the soft transition to the new regulation. The soft transition allows companies to retain certain aspects of the current CE Mark applications while following new registration requirements, if their notified bodies approve. View
Animal Tissue Use in Medical Devices – Webinar Recording/Transcript
$287.00
Implementing compliant systems for medical devices with animal tissue requires multiple control layers, typically using standards in the ISO 22442 family — some of which are under revision. 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
Organizing Data and Document Archives - Webinar Recording/Transcript
$487.00
Are your documents as organized as you think they are? Can you easily put your hands on the documents FDA investigators request? Or are you searching for that needle in a haystack? View
Perform Effective Investigations and CAPAs - Webinar Recording/Transcript
$287.00
The Corrective and Preventive Action (CAPA) process is the heart of any quality management system. And yet, year after year, CAPA violations are the most frequently observed Quality System subsystem cited by FDA regardless of the manufacturers shape or size. View
Investigations Operations Manual 2019
$377.00
The Investigations Operations Manual is the primary policy guide for FDA investigations and directs the conduct of all fundamental field investigational activities. View
Spreadsheet Validation - Webinar Recording/Transcript
$287.00
Perch on the shoulder of an expert to discover potential pitfalls and innovative approaches. Get feedback, resolve pain points and share experiences in real time. View
Get Pre-Certified: Your Software as a Medical Device - Webinar Recording/Transcript
$287.00
Bring your software as a medical device (SaMD) product to market faster with the Software Precertification Program. The pre-cert pathway regulatory model expedites pre-market approval while assessing the safety and effectiveness of your software technologies. View
5 Design Change Considerations to Stay Compliant - Webinar Recording/Transcript
$287.00
Many a medical devicemaker has incurred a warning letter due to slipshod process validation. No wonder. Process validation is an exacting task, subject to strict statistical procedures and hemmed in by 21 CFR §820.75 and ISO 13485:2016. View
