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Statistical Techniques: Analysis of Variance (ANOVA)
Welcome back to another week of MedTech Compliance Chronicles! As we continue building out our toolbox of practical statistical...
ramosstarnesprojec
6 days ago6 min read
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Statistical Techniques: Hypothesis Testing
Welcome back to another week of MedTech Compliance Chronicles! As we continue our exploration of essential statistical techniques for...
ramosstarnesprojec
Apr 155 min read
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Statistical Techniques: Design of Experiments
Welcome back to MedTech Compliance Chronicles! This week, we’re shifting gears from our usual country-specific regulatory requirements to...
ramosstarnesprojec
Apr 18 min read
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Colombia: Maintaining and Renewing Registration
Good afternoon, and welcome back to another week of MedTech Compliance Chronicles! Today, we reach the final post in our assessment of...
ramosstarnesprojec
Mar 163 min read
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Colombia: Medical Device Reporting Requirements
Good day everyone, and welcome back to another week of MedTech Compliance Chronicles! As we continue exploring Colombia’s regulatory...
ramosstarnesprojec
Feb 163 min read
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Colombia: Medical Device Labeling, Packaging, and Advertisement Requirements
Welcome back to another week of MedTech Compliance Chronicles! As we continue our exploration of Colombia’s regulatory framework, this...
ramosstarnesprojec
Feb 24 min read
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Colombia: Required Documentation for Marketing Authorization
Welcome back to another week of MedTech Compliance Chronicles! As we begin the new year, we’re diving into one of the most critical...
ramosstarnesprojec
Jan 195 min read
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Colombia: Medical Device Marketing Authorization and Registration
Welcome back to MedTech Compliance Chronicles! As we continue our journey through Colombia's medical device regulations, this week’s post...
ramosstarnesprojec
Dec 22, 20244 min read
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Colombia: Medical Device Classification
Hello everyone, and welcome back to another week of MedTech Compliance Chronicles! This week, we continue exploring Colombia’s regulatory...
ramosstarnesprojec
Nov 21, 20244 min read
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Introduction to Colombia!
Hello everyone and welcome to a very special post in MedTech Compliance Chronicles! This blog series has so far brought us from knowing...
ramosstarnesprojec
Nov 7, 20243 min read
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Statistical Techniques: Sampling
Hello everybody and welcome back to another week of MedTech Compliance Chronicles! Today we will be dealing a little less directly with...
ramosstarnesprojec
Oct 27, 202410 min read
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Change Control
Hello, everyone and welcome back to another week of MedTech Compliance Chronicles! We have come quite a long way, in fact, we have...
ramosstarnesprojec
Oct 9, 20245 min read
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Market Applications
Welcome back to MedTech Compliance Chronicles! In this week’s post we jump into the key processes of securing FDA market clearance for...
ramosstarnesprojec
Sep 25, 202410 min read
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Post Market Surveillance
Hello everyone and welcome back to another issue of MedTech Compliance Chronicles! We are now right on the heels of putting our medical...
ramosstarnesprojec
Aug 29, 20247 min read
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Medical Device Labeling
Greetings, MedTech enthusiasts! We are finally on the other side of developing and implementing our quality management systems. It has...
ramosstarnesprojec
Aug 15, 20246 min read
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QMS: Internal Audit
Hello and welcome to the final installment of our QMS series on MedTech Compliance Chronicles! We've now navigated through all the...
ramosstarnesprojec
Jul 31, 20246 min read
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QMS: Statistical Techniques
Hello all, and welcome back to MedTech Compliance Chronicles. We have been on our journey of bringing a medical device to market in the...
ramosstarnesprojec
Jul 18, 20246 min read
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QMS: Reportable Events
Hello all and welcome back to another issue of MedTech Compliance Chronicles! This week we will follow our complaint handling post by...
ramosstarnesprojec
Jul 3, 20245 min read
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QMS: Complaint Handling
Welcome back to another week of MedTech Compliance Chronicles! Still exploring the QMS, we are quickly approaching the point where we...
ramosstarnesprojec
Jun 19, 20247 min read
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QMS: Corrective & Preventive Actions
Hello everyone, and welcome to another installment of MedTech Compliance Chronicles! Having tackled the challenges of managing...
ramosstarnesprojec
Jun 5, 20247 min read
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