Blog

News

About this author:

Zuhdi Hussein

Dr. Hussein has over 15 years of experience in the GMP industry as a successful advisor for top medical device and pharmaceutical companies. In 2008 Dr. Hussein was named as an assessor for project management in the “German Society for Project Management” (GPM). Dr. Hussein holds a Master’s in Physics and a Master’s in Biomedical Engineering from the University of Hannover in Germany. He also holds a PhD in Physics from the University of Luebeck in Germany.

10 CAPA Tips for the Medical Device Industry

January 27th, 2016 by

Male Scientist Using Medical ToolsThe CAPA process from the side of regulatory compliance [...] Read More

What Data Integrity Means to Device Manufacturers

August 28th, 2015 by

Data SecurityData integrity is an ever-increasing concern in life sciences, with medical device manufacturers feeling much of [...] Read More

How Compliant Are You with 21 CFR 210 / 211?

April 23rd, 2015 by

Pharmaceutical ManufacturingYou know which rules you’re [...] Read More

The Role of FDA Benefit-Risk Assessment in Regulatory Decision Making

April 7th, 2015 by

FDA Regulations[...] Read More

What Should Drive Your FDA Medical Device Compliance Efforts?

March 27th, 2015 by

Medical Device Compliance[...] Read More

How Compliant Are Your Medical Devices with EU Cloud Computing Regulations?

February 4th, 2015 by

EU Medical Device Cloud Computing Regulations[...] Read More

Is It Time for Your Firm to Undergo an FDA Mock Audit?

January 19th, 2015 by

FDA Mock AuditAmong compliance tools, FDA mock audits are [...] Read More

Understanding the Results of FDA Gap Analysis

October 14th, 2014 by

FDA Gap AnalysisFDA gap analysis helps organizations [...] Read More

Are You Ready to Become Compliant With EU Annex 11?

October 8th, 2014 by

EU Annex 11Compliance[...] Read More

The Applicable Scope of FDA 21 CFR Compliance

September 9th, 2014 by

Electronic SignaturesRegulatory [...] Read More