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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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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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