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Canada: Medical Device License Applications
Welcome back to MedTech Compliance Chronicles! In our ongoing series on Canadian medical device regulations, we now turn to one of the...
ramosstarnesprojec
6 days ago5 min read
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Canada: Marketing a Class I Device (Establishment Licenses, Labeling and Basic PMS)
Hello everybody and welcome back to MedTech Compliance Chronicles! After examining Canadian classification rules and detailing the...
ramosstarnesprojec
Jul 165 min read
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Canada: Safety and Effectiveness Requirements
Hello everybody and welcome back to another issue of MedTech Compliance Chronicles! Now that we have worked out how our device is...
ramosstarnesprojec
Jul 14 min read
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Canada: Classifying Your Medical Device in Canada
Hello everyone and welcome back to Medtech Compliance Chronicles! Now that we have a general idea of who Health Canada is and what they...
ramosstarnesprojec
Jun 177 min read
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Canada: Introduction to Health Canada
Welcome back to MedTech Compliance Chronicles! After a short break exploring key statistical techniques essential for compliance in any...
ramosstarnesprojec
Jun 14 min read
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Statistical Techniques: Measurement System Analysis
Hello everyone, and welcome back to MedTech Compliance Chronicles! This week, we are continuing to build on some of the statistical...
ramosstarnesprojec
May 186 min read
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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
Apr 276 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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