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
Garmin to Develop Wearables for Remote Patient Monitoring
Garmin notes that the use of wearables as health and medical tools is rapidly evolving and the company is “committed to the development of wearables that can lead to the detection of serious health conditions.”
CMS Report: Retail Drug Spending Slowed in 2017
CMS said the catalysts for slower retail drug spending include slower growth in the number of prescriptions dispensed and slower volume growth of expensive drugs.
FDA Approves Tecentriq Plus Avastin and Chemotherapy for NSCLC
The agency based its approval on a Phase 3 trial that showed the regimen led to patients living significantly longer than with Avastin and chemotherapy alone. 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
HiberGene Earns CE Mark for Rapid Flu Test
The test can be performed on the company’s HG Swift analyser to test four samples simultaneously. 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
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
