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
Awareness of support in ISO 9001 – Lecture 11
Lecture summary: The implementation of awareness procedures should be a priority of your business Make the employee aware of the aspects and hazards, and the...
Competence in Support of ISO 9001 – Lecture 10
Lecture summary: The company has to decide what particular competencies are needed to perform his/her job correctly Once you determine the competence, you will see...
Top 5 trends in the MedDev industry for 2021
With the aim to keep track of where healthcare technology is going, studying tech trends is essential. The MedDev industry is always looking for alternative...
What is Resource Management in the medical device world – Lesson 8
As a requirement within ISO 13485, the management must ensure that adequate resources are available to perform continuous work by the organization. Providing resources can...
Work environment and contamination control according to ISO 13485 – Lesson 9
Work environment and contamination control are important and critical for effective and compliant medical device business run. Definition of the Working Environment Work conditions and...
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...
