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.
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AdvaMed Says Abbreviated 510(k) Guidance Needs More on Device Types
The draft guidance says source criteria will come from FDA staff, literature, and data from existing devices, but it makes no mention of input from healthcare professionals and other stakeholders.
Expert Group Approves Safety, Efficacy of GSK’s Malaria Drug
“I thought the efficacy data was very strong,” said committee member Dean Follmann, assistant director for biostatistics at the National Institute of Allergy and Infectious Diseases. “When we do a pooled analysis to compare it to primaquine we see they’re very similar.”
Drug Distributors Challenge New York Law Over Opioid Fines
The surcharge on pharmaceutical manufacturers and wholesale distributors will “punish those companies for the opioid epidemic, the roots of which are… 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
French Company Receives CE Mark for Laparoscopic Applicator
The device’s additional indication allows the device to be used for hemostasis when controlling bleeding in classical procedures is impractical, ineffective or impossible during… 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.
The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium
The 21st Century Take on Observational Studies walks you through everything you need to know about the opportunities and pitfalls observational studies can offer. The report looks at the growing trend toward observational research and how provisions in the 21st Century Cures Act create even more incentives to rely on real-world evidence in the development of medical products.
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