Every quality management system begins with a Quality Policy. It is usually one of the first documents auditors ask to see, and for many organizations it becomes a statement that hangs in conference rooms or gets recited during onboarding. However, behind the formality is a deeper purpose. The Quality Policy is more than a required document; it is the organization’s declaration of intent. It establishes why the company exists in the context of quality and what it is fundament

Welcome back to MedTech Compliance Chronicles! As we have already discussed, in Canada, manufacturers of Class II, III, and IV medical devices must hold a Medical Device License before selling their device. However, once a device has been licensed by Health Canada, the license must accurately reflect the device as it exists on the market. Any changes that may affect its design, performance, safety, or intended use must be carefully evaluated to determine whether they require

Good day everyone, here at MedTech Compliance Chronicles, we have been exploring how Canada regulates medical devices for quite some...

Welcome back to MedTech Compliance Chronicles! This week we are turning our attention to one of the most important responsibilities...

Welcome back to MedTech Compliance Chronicles! This week we will be discussing one of the most critical aspects of medical device...

Welcome back to MedTech Compliance Chronicles! In our ongoing series on Canadian medical device regulations, we now turn to one of the...

Hello everybody and welcome back to MedTech Compliance Chronicles! After examining Canadian classification rules and detailing the...

Hello everybody and welcome back to another issue of MedTech Compliance Chronicles! Now that we have worked out how our device is...

Hello everyone and welcome back to Medtech Compliance Chronicles! Now that we have a general idea of who Health Canada is and what they...

Welcome back to MedTech Compliance Chronicles! After a short break exploring key statistical techniques essential for compliance in any...

Hello everyone, and welcome back to MedTech Compliance Chronicles! This week, we are continuing to build on some of the statistical...

Welcome back to another week of MedTech Compliance Chronicles! As we continue building out our toolbox of practical statistical...

Welcome back to another week of MedTech Compliance Chronicles! As we continue our exploration of essential statistical techniques for...

Welcome back to MedTech Compliance Chronicles! This week, we’re shifting gears from our usual country-specific regulatory requirements to...

Good afternoon, and welcome back to another week of MedTech Compliance Chronicles! Today, we reach the final post in our assessment of...

Good day everyone, and welcome back to another week of MedTech Compliance Chronicles! As we continue exploring Colombia’s regulatory...

Welcome back to another week of MedTech Compliance Chronicles! As we continue our exploration of Colombia’s regulatory framework, this...

Welcome back to another week of MedTech Compliance Chronicles! As we begin the new year, we’re diving into one of the most critical...

Welcome back to MedTech Compliance Chronicles! As we continue our journey through Colombia's medical device regulations, this week’s post...

Hello everyone, and welcome back to another week of MedTech Compliance Chronicles! This week, we continue exploring Colombia’s regulatory...