Articles (Blog)
Medical Device QMS Blog
The qmsWrapper blog shares insights on medical device quality management systems, ISO 13485 compliance, regulatory frameworks, and practical guidance for MedTech teams building compliant products.
Topics we cover
- Medical Device QMS
- ISO 13485 Compliance
- Risk Management (ISO 14971)
- Regulatory Strategy (FDA, MDR, IVDR)
- Traceability & Design Control
- CAPA and Quality Events
What is considered by the planning of your product realization as per ISO 13485 – Lesson 10
Naturally, planning goes ahead of realization. And this part of the standard explains how important is for you to be consistent in planning throughout all...
Customer-related processes – Lesson 11
Depending on the medical device type you can assume who are potential users of the same. After you define that, you will easier understand this...
From A to Z about Design and Development of medical device ISO 13485:2016 – Lesson 12
The design and development of the medical device are one of the most crucial parts of the ISO 13485 standard due to its complexity compared...
What is Purchasing process in design and development in ISO 13485 – Lesson 13
In the medical device industry, it’s not just purchasing. ISO 13485 standard has some strict rules when it comes down to purchase from suppliers. The...
Medical device Production and service provision in ISO 13485 – Lesson 14
ISO 13485 standard intends to cover a wide range of manufacturing, therefore, it’s a bit generalized when it comes to defining applicable requirements and service...
Control of monitoring and measuring equipment in the medical device industry – Lesson 15
The ISO 13485 standard treats monitoring and measuring devices very seriously. Every medical device company must have had plenty of various equipment for measuring and...
How ISO 13485 explains Measurement, analysis, and improvement – Lesson 16
Your medical device and its quality process must be measured, monitored, analyzed, reported, and reviewed. It's done by using a system of measurement-analysis-improvement that is...
Monitoring and measurement according to ISO 13485 – Lesson 17
What mostly reflects the effectiveness of the Quality Management System is monitoring and measurement focus on the quality of your medical device. The ISO 13485...
Control of nonconforming products in ISO 13485 – Lesson 18
The ISO 13485 covers all phases of the medical device lifecycle and one that must be covered is also the control of nonconforming products. It’s...
