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Meet the Engineer: Will Brown

Meet the Engineer: Will Brown Welcome to the second post in our “Meet the Engineer” series! Read below to find out makes GCI engineers more effective and efficient than the rest, as well as some useful advice for prospective GCI candidates from one of our project leads, Will Brown. Why ...
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Meet the Engineer: Adrien Nicolas

Meet the Engineer: Adrien Nicolas Welcome to the first post in our “Meet the Engineer” series – a new way to get an in-depth look into the people who make GCI the industry leader for quality and compliance support for medical device companies, as well as an energetic and gratifying ...
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5 Steps to Selecting Risk-Based Sampling Plans for Optimal Process Validation

5 Steps to Selecting Risk-Based Sampling Plans for Optimal Process Validation Most engineers choose the smallest sample size possible without considering whether their process AQLs can actually meet the requirements of the sampling plan.  Many times, this is the root cause of failing to meet acceptance criteria in validation studies ...
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ISO 13485 2016 Revision Summary

ISO 13485 : 2016  Revision A   Summary   of   the  Updated   Standard ISO 13485 – the internationally recognized quality management systems standard for the medical device industry – has been updated after thirteen years. The final version of this standard was published on March 1st, 2016. Soon after, ...
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2016 FDA Science Priorities

FDA Releases Science Priorities for 2016 The Regulatory Science and Policy Subcommittee (RSS) recently released the top ten regulatory science needs. Annually, this subcommittee collects the reported gaps from the CDRH offices and uses this information to asses the following year’s regulatory science needs. Here’s a recap on what you need ...
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More Foreign Device Inspections Will Impact Production, Process Controls

More Foreign Device Inspections Will Impact Production, Process Controls In 2014, CDRH conducted 594 foreign device inspections, almost doubling the number of foreign inspections it conducted the previous year. An increase in outsourcing is pushing the FDA to conduct more foreign inspections, but it also means that there is more ...
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Considerations When Using Postmarket Data in Risk Management

Considerations When Using Postmarket Data in Risk Management The key to integrating complaint handling and risk management is to ensure feeder processes are in place to bring data from the post-market surveillance group to the risk management tools, in the form of: Adding new or previously unforeseeable hazards, hazardous situations, ...
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The Integration of Complaint Handling and Risk Management

The Integration of Complaint Handling and Risk Management In another first for warning letters, complaint handling supplanted CAPA as the violation found most in letters.1 Medical device manufacturers often struggle to keep up with complaint investigations and MDRs, but that’s not even their biggest challenge. The biggest challenge is establishing and ...
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FDA Audit Preparation

Can I use my audit company to remediate our Quality Systems?

Can I use my audit company to remediate our Quality Systems? You want to be ready for that upcoming FDA or Notified Body audit, right?  You want to sail through with few, if any non-conformities, look good to your boss, and be able to ensure your continued position or promotion ...
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FDA approves first molecular (gene-based) test to determine red blood cell types in transfusion medicine

FDA approves first molecular (gene-based) test to determine red blood cell types in transfusion medicine The U.S. Food and Drug Administration today approved the Immucor PreciseType Human Erythrocyte Antigen (HEA) Molecular BeadChip Test — the first FDA-approved molecular assay used in transfusion medicine to assist in determining blood compatibility. The ...
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