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![Colombia: Medical Device Labeling, Packaging, and Advertisement Requirements](https://static.wixstatic.com/media/60601f_152b18c1d60949fc96ee8146d3666240~mv2.jpg/v1/fill/w_454,h_341,fp_0.50_0.50,q_90,enc_auto/60601f_152b18c1d60949fc96ee8146d3666240~mv2.webp)
ramosstarnesprojec
Feb 24 min read
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...
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![Colombia: Required Documentation for Marketing Authorization](https://static.wixstatic.com/media/60601f_8cfb9057c248463bbaf195c0cb0c9c75~mv2.jpg/v1/fill/w_454,h_341,fp_0.50_0.50,q_90,enc_auto/60601f_8cfb9057c248463bbaf195c0cb0c9c75~mv2.webp)
ramosstarnesprojec
Jan 195 min read
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...
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![Colombia: Medical Device Marketing Authorization and Registration](https://static.wixstatic.com/media/60601f_5e2fa9068e5044329ff74c94e790b18f~mv2.png/v1/fill/w_454,h_320,fp_0.50_0.50,q_95,enc_auto/60601f_5e2fa9068e5044329ff74c94e790b18f~mv2.webp)
ramosstarnesprojec
Dec 22, 20244 min read
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...
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![Colombia: Medical Device Classification](https://static.wixstatic.com/media/60601f_7bdb99d8955241519e1e3d7703c8dedb~mv2.png/v1/fill/w_454,h_341,fp_0.50_0.50,q_95,enc_auto/60601f_7bdb99d8955241519e1e3d7703c8dedb~mv2.webp)
ramosstarnesprojec
Nov 21, 20244 min read
Colombia: Medical Device Classification
Hello everyone, and welcome back to another week of MedTech Compliance Chronicles! This week, we continue exploring Colombia’s regulatory...
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![Introduction to Colombia!](https://static.wixstatic.com/media/60601f_753b60fd6a6147c19ab8a1a5e54531dd~mv2.png/v1/fill/w_454,h_341,fp_0.50_0.50,q_95,enc_auto/60601f_753b60fd6a6147c19ab8a1a5e54531dd~mv2.webp)
ramosstarnesprojec
Nov 7, 20243 min read
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...
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![Statistical Techniques: Sampling](https://static.wixstatic.com/media/60601f_ac885cd4786b48998a38052e162afbf2~mv2.jpg/v1/fill/w_454,h_341,fp_0.50_0.50,q_90,enc_auto/60601f_ac885cd4786b48998a38052e162afbf2~mv2.webp)
ramosstarnesprojec
Oct 27, 202410 min read
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...
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![Change Control](https://static.wixstatic.com/media/60601f_c2dc3c9bedfd4abb8d4ad943b1dc0287~mv2.webp/v1/fill/w_454,h_341,al_c,q_90,enc_auto/60601f_c2dc3c9bedfd4abb8d4ad943b1dc0287~mv2.webp)
ramosstarnesprojec
Oct 9, 20245 min read
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...
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![Market Applications](https://static.wixstatic.com/media/60601f_3ec9592240814f51a7558ee720fcb6b4~mv2.webp/v1/fill/w_454,h_341,al_c,q_90,enc_auto/60601f_3ec9592240814f51a7558ee720fcb6b4~mv2.webp)
ramosstarnesprojec
Sep 25, 202410 min read
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...
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![Post Market Surveillance](https://static.wixstatic.com/media/60601f_0e1b968b338345938a63c9e1481ea313~mv2.webp/v1/fill/w_454,h_341,al_c,q_90,enc_auto/60601f_0e1b968b338345938a63c9e1481ea313~mv2.webp)
ramosstarnesprojec
Aug 29, 20247 min read
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...
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![Medical Device Labeling](https://static.wixstatic.com/media/60601f_97d002472aa34d81a398e44a9aa17131~mv2.jpg/v1/fill/w_454,h_341,fp_0.50_0.50,q_90,enc_auto/60601f_97d002472aa34d81a398e44a9aa17131~mv2.webp)
ramosstarnesprojec
Aug 15, 20246 min read
Medical Device Labeling
Greetings, MedTech enthusiasts! We are finally on the other side of developing and implementing our quality management systems. It has...
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![QMS: Internal Audit](https://static.wixstatic.com/media/60601f_1215e0a7f9fc43f8a5ea7cec355df31b~mv2.jpg/v1/fill/w_454,h_341,fp_0.50_0.50,q_90,enc_auto/60601f_1215e0a7f9fc43f8a5ea7cec355df31b~mv2.webp)
ramosstarnesprojec
Jul 31, 20246 min read
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...
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![QMS: Statistical Techniques](https://static.wixstatic.com/media/60601f_0de68d594e5a458f9e33d7b9e758dacb~mv2.webp/v1/fill/w_454,h_341,al_c,q_90,enc_auto/60601f_0de68d594e5a458f9e33d7b9e758dacb~mv2.webp)
ramosstarnesprojec
Jul 18, 20246 min read
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...
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![QMS: Reportable Events](https://static.wixstatic.com/media/60601f_b27891a6d5014b6aaea3518b13483fdd~mv2.jpg/v1/fill/w_281,h_179,fp_0.50_0.50,q_90,enc_auto/60601f_b27891a6d5014b6aaea3518b13483fdd~mv2.webp)
ramosstarnesprojec
Jul 3, 20245 min read
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...
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![QMS: Complaint Handling](https://static.wixstatic.com/media/60601f_acb84a61b2ba4298927a28079a80027d~mv2.webp/v1/fill/w_454,h_341,al_c,q_90,enc_auto/60601f_acb84a61b2ba4298927a28079a80027d~mv2.webp)
ramosstarnesprojec
Jun 19, 20247 min read
QMS: Complaint Handling
Welcome back to another week of MedTech Compliance Chronicles! Still exploring the QMS, we are quickly approaching the point where we...
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![QMS: Corrective & Preventive Actions](https://static.wixstatic.com/media/60601f_f26673d371e8422a8552a1cbec64729a~mv2.jpg/v1/fill/w_454,h_341,fp_0.50_0.50,q_90,enc_auto/60601f_f26673d371e8422a8552a1cbec64729a~mv2.webp)
ramosstarnesprojec
Jun 5, 20247 min read
QMS: Corrective & Preventive Actions
Hello everyone, and welcome to another installment of MedTech Compliance Chronicles! Having tackled the challenges of managing...
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![QMS: Nonconforming Product](https://static.wixstatic.com/media/60601f_53e34a83c0d541ae9cec904e85ae7c6c~mv2.webp/v1/fill/w_454,h_341,al_c,q_90,enc_auto/60601f_53e34a83c0d541ae9cec904e85ae7c6c~mv2.webp)
ramosstarnesprojec
May 22, 20245 min read
QMS: Nonconforming Product
Welcome back to another installment of MedTech Compliance Chronicles! Over the past few posts, we've been diligently ironing out our...
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![QMS: Monitoring and Measurement](https://static.wixstatic.com/media/60601f_ea9f4d4557d74f6280db48d91f9be4f3~mv2.jpg/v1/fill/w_454,h_341,fp_0.50_0.50,q_90,enc_auto/60601f_ea9f4d4557d74f6280db48d91f9be4f3~mv2.webp)
ramosstarnesprojec
May 8, 20245 min read
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...
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![QMS: Finalizing Production Requirements](https://static.wixstatic.com/media/60601f_9276e0c8fbab414b882f6f3d06421854~mv2.jpg/v1/fill/w_454,h_341,fp_0.50_0.50,q_90,enc_auto/60601f_9276e0c8fbab414b882f6f3d06421854~mv2.webp)
ramosstarnesprojec
Apr 24, 20245 min read
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...
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![QMS: Process Validation](https://static.wixstatic.com/media/60601f_235245b5d9244c73b77a7dc376d80c73~mv2.webp/v1/fill/w_454,h_341,al_c,q_90,enc_auto/60601f_235245b5d9244c73b77a7dc376d80c73~mv2.webp)
ramosstarnesprojec
Apr 17, 20248 min read
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...
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![QMS: Identification & Traceability](https://static.wixstatic.com/media/60601f_c02c2fd246e144faad4c34626d1cc42d~mv2.webp/v1/fill/w_454,h_341,al_c,q_90,enc_auto/60601f_c02c2fd246e144faad4c34626d1cc42d~mv2.webp)
ramosstarnesprojec
Apr 10, 20245 min read
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...
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