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
Understanding the organization and its context – Lecture 2
Lecture summary: Understanding the context of your organization is key to a correct business strategy You need to consider only issues that can affect customer...
Leadership and commitment – Lecture 3
Lecture summary: Top management will have to supply evidence for its actions and improvements of QMS if they want to prove their commitment ISO 9001...
What are the Management Responsibilities according to ISO 13485 – Lesson 4
Management has an absolute responsibility to foster the quality policy, confirm its alignment, and communicates the mission to employees. They have a responsibility to plan, delegate authority,...
Essentials of Documentation requirements in ISO13485 – Lesson 3
You will see in the end, it’s all about documentation. If not in this part then by the end you will perceive the importance of...
Policy: establishing and communicating the quality policy – Lecture 4
Lecture summary: The quality policy is a document where you should state your commitment to your improvement You need to apply it throughout the organization...
What are the General requirements in ISO 13485 – Lesson 2
Every ISO standard has the system of requirements and each one of them is described in segments. In general requirements, it’s established what is meant by: Developing and...
Organizational Roles, Responsibilities, and Authorities – Lecture 5
Lecture summary: Top Management is by definition a person or group of people who instruct and control an organization at the highest level (within the...
Understand ISO 13485 – Lesson 1
Let’s say you have an idea of placing an innovative medical device on the market. That’s great, but you already know that going from idea to actual...
5 FAQs about ISO 13485
1. What is an ISO 13485? ISO 13485 is an international standard for establishing quality management in the medical device industry. It is an effective explanation...
