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
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,...
Post-market surveillance (PMS) of medical devices
Let’s try to clear out all the mystery that stands behind this statement. We’ll start with its definition from the previous article where we have defined basic...
Resources of Support – Lecture 9
Lecture summary: The ISO 9001 Standard refers to five kinds of resources: human resources, knowledge, processes environment, infrastructures, and monitoring and measuring resources. Each one...
What is medical devices lifecycle
The Medical Device life cycle is considered a development of the product, from the very beginning to the end. What is the beginning, what is involved in...
How to do an Offsite Audits
An offsite audit is the same as an on-site QMS audit, but the auditor engages with you via technology. The Initial Preparation Prior to starting the...
Extraordinary circumstances require extraordinary measures-Offsite auditing
Certain audits of medical devices and processes are essential for MedDev companies if they want to place their product on the European market. However, audits are not used...
Basic Terms in Medical Device Industry
We can’t emphasize enough how important is to understand the language of medical devices. To meet the requirements and the Regulations it’s essential to understand...
