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
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...
Meet qmsWrapper’s Project Manager and find out more about new features
qmsWrapper is a successful company promoting the organizational framework that provides structure to the processes, policies, procedures, and resources to implement the Quality Management System for medical device startups....
Planning: Actions to address risks and opportunities – Lecture 6
Lecture summary When planning how to address risks and opportunities the best way is risk-based thinking Risk-based thinking will guide your top management to make...
All that you need to know about Medical devices Class I
Medical devices are devices whose purpose is to benefit patients. They are usually used by doctors and healthcare providers to help them diagnose and treat...
The Wetling Company’s eQMS-journey
We live in a time of technological evolution and the medical device industry is no exception. Technology advances day-by-day. The Wetling Company, with its revolutionary new wound-healing technology,...
Quality objectives and planning to achieve them – Lecture 7
Summary lecture: Quality objectives are one of the requirements of ISO 9001 standard and it aims to improve your company’s QMS One of the best...
Premarket approval (PMA) or notification (510k)
When someone is talking about pre-market approval or notification known as 510(k), they have in mind the US market. In the EU, the concept to get to the...
Planning of changes – Lecture 8
Lecture Summary: When some changes happen in your QMS, you need to carry them out in a planned manner Changes are intended to be beneficial,...
