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 of both U.S. FDA requirements (21 CFR 820.100) and EU regulatory requirements ([...] 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 the conformity backlash. There continues to be heightened regulatory focus on diverse cybersecurity topics, including data integrity.

Public and private sector organizations [...] Read More

How Compliant Are You with 21 CFR 210 / 211?

April 23rd, 2015 by

Pharmaceutical ManufacturingYou know which rules you’re responsible for following, but is that enough? Agencies like the FDA rarely make exceptions for firms that misinterpret the law, and although you may be able [...] Read More

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

April 7th, 2015 by

FDA RegulationsPharmaceutical manufacturers can’t sell their products without first convincing regulators of their safety. Firms that fail to do so sustain fiscal losses when they [...] Read More

What Should Drive Your FDA Medical Device Compliance Efforts?

March 27th, 2015 by

Medical Device ComplianceHow do your compliance efforts impact the profitability of the goods you produce? Medical device manufacturers must comply with FDA standards to spread their products to as many markets as possible.

While [...] Read More

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

February 4th, 2015 by

EU Medical Device Cloud Computing RegulationsCloud computing architectures vary widely. In addition to incorporating tons of different device types, they also use diverse routing, layer networking and messaging protocols. These essential variances [...] 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 undeniably useful. By giving GxP-regulated organizations the chance to see how their operations would stack up against real-life inspectors, they make it easier to target and solve outstanding issues. [...] Read More

Understanding the Results of FDA Gap Analysis

October 14th, 2014 by

FDA Gap AnalysisFDA gap analysis helps organizations quantify the differences between their real-world operations and the compliance rules that govern them. For instance, regulated firms commonly [...] Read More

Are You Ready to Become Compliant With EU Annex 11?

October 8th, 2014 by

EU Annex 11ComplianceIf you engage in GMP-regulated actions, use computers in any facility and wish to market your products in the EU, you’ll need to become familiar with EU [...] Read More

The Applicable Scope of FDA 21 CFR Compliance

September 9th, 2014 by

Electronic SignaturesRegulatory compliance is important for any life-sciences firm, but the breadth of your responsibilities won’t always be immediately clear. For instance, you may be well aware of the fact that 21 CFR Part 11 [...] Read More