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FastQS

FastQS

The True Cost of Paper-Based Complaint Handling

Sometimes the most difficult task of a regulatory and quality (RAQA) department is convincing executive management to invest in a…

Feb 1, 2016

The True Cost of Paper-Based Complaint Handling

Feb 1, 2016

FastQS

The Gold Standard: Complaint Handling Workflow

At 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, 2015

The Gold Standard: Complaint Handling Workflow

Dec 22, 2015

FastQS

Statistical Techniques for Medical Device Companies

Probably one of the more ambiguous parts of FDA Part 820, Quality System Regulations is the requirement to make decisions based on…

Nov 9, 2015

Statistical Techniques for Medical Device Companies

Nov 9, 2015

FastQS
in
Inspection Series

Inspection Series: Outside of the Audit Room

This is the second installment of the Inspection Series Publication where we go through topics to prepare and expect during an FDA…

Oct 26, 2015

Inspection Series: Outside of the Audit Room

Oct 26, 2015

FastQS

Six Sections That Need To Be In Your Complaint Handling Procedure

For regulatory and quality teams, writing and maintaining procedures is a critical responsibility to keep medical device companies…

Oct 19, 2015

Six Sections That Need To Be In Your Complaint Handling Procedure

Oct 19, 2015

FastQS

ISO 13485:201X Goes Through Final Draft Revisions

FastQS recently spoke with Mr. Wil Vargas, the Secretary of Technical Committee 210 (TC 210) which is in charge of updating and revising…

Oct 12, 2015

ISO 13485:201X Goes Through Final Draft Revisions

Oct 12, 2015

FastQS

Core Input is now FastQS

After several weeks in development, we’re finally putting the finishing touches on our new name.

Oct 5, 2015

Core Input is now FastQS

Oct 5, 2015

FastQS
in
Inspection Series

Inspection Series: Logs

Introduction

Sep 23, 2015

Inspection Series: Logs

Sep 23, 2015

FastQS

Medical 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, 2015

Medical Device Single Audit Program (MDSAP)

Sep 10, 2015

FastQS

Compliance and Quality

In a medical device company, it’s sometimes difficult to tell the difference between compliance and quality. The “Quality” department of a…

Aug 13, 2015

Compliance and Quality

Aug 13, 2015

FastQS

FastQS

Our mission is to help medical device companies build safer products and maintain compliance. We provide a cloud-based QMS solution.

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