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
FDA to Address ‘Narrow’ Labeling of In Vitro Companion Devices for Oncology Drugs
FDA Commissioner Scott Gottlieb noted an increase in new drugs targeting specific molecular markers that drive the growth and spread of cancer.
Gilead’s HIV Drug Approved in China
Descovy received FDA and European Commission marketing approval in 2016.
FDA Recognizes First Human Genetic Variant Database
Genetic test developers can use the data to support the clinical validity of their tests. Read More
483sOnline.com Your Personal Pre-inspection Toolkit
Rest easy knowing you can identify exactly what FDA investigators are focusing on – before they show up! Read More
FDA OK’s Mobile App for Assisting Opioid Use Disorder Treatments
The app can serve as a training, monitoring and reminder tool for OUD patients and health care providers. Read More
International Devices and Diagnostics Monitor
Stay ahead of the competition with this resource that brings you a global picture of the medical device regulations that affect your business. Read More
Data Integrity in the EU: Requirements for Quality Management Systems
You’ll understand all the requirements with Data Integrity in the EU: Requirements for Quality Management Systems. This report details the ins and outs of all three documents and explains how the FDA regulations fit in.
510(k) Change Analysis: Complying with FDA’s Final Guidances
Order your copy of the 510(k) Change Analysis brief for step-by-step instruction on deciding whether you need to submit a new 510(k) if you change an existing device.
Clinical Research Manual
Clinical Research Manual brings together guidance on everything from pharmacokinetics and study design, to recruitment, monitoring, statistics… all the problem compliance areas you need to stay on top of to conduct clinical trials that will stand up to regulatory scrutiny.
The Solutions Center
