FastQSThe True Cost of Paper-Based Complaint HandlingSometimes the most difficult task of a regulatory and quality (RAQA) department is convincing executive management to invest in a…Feb 1, 2016Feb 1, 2016
FastQSThe Gold Standard: Complaint Handling WorkflowAt FastQS, we think a lot about how to make a quality system easier to maintain. After all, a system that’s easier to maintain often…Dec 22, 2015Dec 22, 2015
FastQSStatistical Techniques for Medical Device CompaniesProbably one of the more ambiguous parts of FDA Part 820, Quality System Regulations is the requirement to make decisions based on…Nov 9, 2015Nov 9, 2015
FastQSinInspection SeriesInspection Series: Outside of the Audit RoomThis is the second installment of the Inspection Series Publication where we go through topics to prepare and expect during an FDA…Oct 26, 2015Oct 26, 2015
FastQSSix Sections That Need To Be In Your Complaint Handling ProcedureFor regulatory and quality teams, writing and maintaining procedures is a critical responsibility to keep medical device companies…Oct 19, 2015Oct 19, 2015
FastQSISO 13485:201X Goes Through Final Draft RevisionsFastQS recently spoke with Mr. Wil Vargas, the Secretary of Technical Committee 210 (TC 210) which is in charge of updating and revising…Oct 12, 20151Oct 12, 20151
FastQSCore Input is now FastQSAfter several weeks in development, we’re finally putting the finishing touches on our new name.Oct 5, 2015Oct 5, 2015
FastQSMedical Device Single Audit Program (MDSAP)The FDA is currently piloting a program with regulatory administrations in Australia, Canada, Japan and Brazil (and the European Union and…Sep 10, 2015Sep 10, 2015
FastQSCompliance and QualityIn a medical device company, it’s sometimes difficult to tell the difference between compliance and quality. The “Quality” department of a…Aug 13, 2015Aug 13, 2015