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QMS: Nonconforming Product
Welcome back to another installment of MedTech Compliance Chronicles! Over the past few posts, we've been diligently ironing out our...
ramosstarnesprojec
May 22, 20245 min read
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QMS: Monitoring and Measurement
Hello everyone and welcome back to another week of MedTech Compliance Chronicles! Over the past couple of weeks we have explored the US...
ramosstarnesprojec
May 8, 20245 min read
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QMS: Finalizing Production Requirements
Hello everyone and welcome back to another week of MedTech Compliance Chronicles! We are slowly but surely winding down on the QMS...
ramosstarnesprojec
Apr 24, 20245 min read
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QMS: Process Validation
Good day everyone and welcome back to another week of MedTech Compliance Chronicles. Today we will go over a topic that, for many, is...
ramosstarnesprojec
Apr 17, 20248 min read
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QMS: Identification & Traceability
Hello all and welcome back to another week of MedTech Compliance Chronicles. As we continue down our path to product realization we are...
ramosstarnesprojec
Apr 10, 20245 min read
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QMS: Purchasing Controls
Hello everyone and welcome back to another week of MedTech Compliance Chronicles! This week we are continuing our exploration of the...
ramosstarnesprojec
Apr 3, 20246 min read
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QMS: Design & Development
Hello all and welcome back to MedTech Compliance Chronicles. Following the previous two week’s posts about the requirements for planning...
ramosstarnesprojec
Mar 27, 20246 min read
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QMS: Risk Management
Good day to all and welcome back to another week of MedTech Compliance Chronicles! This week we focus on one of the most core,...
ramosstarnesprojec
Mar 20, 20246 min read
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QMS: Planning for Product Realization
Welcome back to MedTech Compliance Chronicles! Continuing our journey through the Quality Management System (QMS), we shift our focus...
ramosstarnesprojec
Mar 13, 20244 min read
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QMS: Resource Management
Good day to all and welcome back to another week of MedTech Compliance Chronicles. Last week we spoke about management responsibilities...
ramosstarnesprojec
Feb 27, 20245 min read
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QMS: Management Responsibility
Hello all and welcome to another week of MedTech Compliance Chronicles. After a couple weeks of setting the foundations of the QMS we are...
ramosstarnesprojec
Feb 20, 20246 min read
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QMS: Document Control
Good day to all and welcome back to another week of MedTech Compliance Chronicles. This week our topic is document control. It was a...
ramosstarnesprojec
Feb 13, 20245 min read
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QMS: Process Approach
Hello and welcome to another week of MedTech Compliance Chronicles! Last week we learned about what a Quality Management System (QMS) is...
ramosstarnesprojec
Feb 6, 20245 min read
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Introducing the Quality Management System
Welcome to week 4 of MedTech Compliance Chronicles! This week is a special one. Today’s post will be the first in a series about...
ramosstarnesprojec
Jan 30, 20245 min read
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Classifying Your Medical Device
Hello everyone and welcome back to MedTech Compliance Chronicles. Last week we took a pretty detailed look into how the US FDA classifies...
ramosstarnesprojec
Jan 23, 20243 min read
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How the FDA Classifies Medical Devices
Hello everyone and welcome back to MedTech Compliance Chronicles. Now that we have determined our product is a medical device the next...
ramosstarnesprojec
Jan 16, 20245 min read
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MedTech Compliance Chronicles: Navigating FDA Regulations
Is your product a Medical Device? Good evening to all and welcome to the MedTech Compliance Chronicles: Navigating FDA Regulations blog....
ramosstarnesprojec
Jan 7, 20246 min read
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