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 Brings Back More Staff for Inspection Activities
Approximately 100 staff members will carry out inspections of high risk medical device manufacturing facilities.
Sen. Sanders, Rep. Cummings Introduce Bill Package to Lower Drug Costs
Rep. Khanna said the bill “will bring down drug prices by taking on monopolies and boosting prescription drug competition.”
Supreme Court Refuses Merck’s Appeal Over $200 Million Gilead Verdict
The judge said Merck’s actions were “even more egregious because the main perpetrator of its misconduct was its attorney.” 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 Clears Applied Tissue’s Platform Wound Dressing
The device applies an even distribution of negative pressure across the wound. 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
