Quality Management
Quality Management is all about, um, ensuring quality in your company. If that sounds weird, you’re not alone! Hopefully our articles can help.
The Medical Device Product Development Journey: A Phase-by-Phase Guide
So, you have an idea for a medical device? Awesome! But how do you get from that "aha!" moment to a finished product that's safe, effective, and compliant?...
Creating Turtle Diagrams for MDR & FDA Compliance
In the highly regulated world of medical devices, demonstrating robust process control isn't just good practice – it's a regulatory necessity. Both the EU...
Medical Device Codes: EMDN, UMDNS, GMDN and MDR
Once you embark on your regulatory journey towards CE certification, you will inevitably come across the strange land of medical device codes. It's not...
QMS Quality Manual: Quality Policy and Quality Objectives
You are just starting to set up your QMS quality manual? When setting up your QMS, this is one of the first documents slammed at your face. You describe your...
Software Validation: How To Do It (Pain From Hell)
Let me just start by saying that I think software validation is complete crap and an utterly unnecessary activity invented by regulators and bureaucrats....
Post-Market Surveillance: The Ultimate Guide under MDR
Okay, you managed the ISO 13485 certification, walked through endless discussions with your notified body and finally you can put the CE sticker on your...
ISO 13485 KPIs: Example Key Performance Indicators For Your ISO 13485 Processes
KPIs are like scorecards for organizations, helping them track how well they’re doing and if they’re moving closer to their goals. In the world of ISO 13485...
Supplier Management Under ISO 13485:2016
Let’s look at how to perform supplier management under the ISO 13485:2016. Effective supplier management is critical for controlling risks, ensuring the...
CAPA (Corrective and Preventive Action): What Is It and How To Be Compliant?
So, when you start out on your exciting (yes) regulatory journey, pretty early on you’re going to come across the word “CAPA”. Seasoned regulatory...