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
Control of Nonconforming Outputs – Lecture 20
Lecture summary: You must control nonconforming outputs in its processes, its products, or services. You should take appropriate action based on the nature of nonconformity...
Release of products and services – Lecture 19
Lecture summary: The ISO 9001 standard talks about the need to implement planned arrangements. You have to ensure that the product meets specifications and is...
Production and service provision – Lecture 18
Lecture summary: The production and service provision process needs to be performed under controlled conditions One of the methods you can use to control the...
Control of externally provided processes, products, and services – Lecture 17
Lecture summary: An external provider is an interested party in the organization, though independent from the organization’s QMS. You must communicate with the external supplier...
Design and Development of products and services – Lecture 16
Lecture summary: D&D includes phases from planning, inputs, controls, outputs, and changes Practically, you need to have certain some type of design discipline as it...
Requirements for products and services – Lecture 15
Lecture summary: The ISO 9001 Standard requires the initiation of communication with the customer relating to products and services Must be ensured that requirements are...
Operational planning and control – Lecture 14
Lecture summary: Operational planning is about controlling the design and development process. Identify all the specifications and characteristics of a product including quality requirements. Define...
Documented information – Lecture 13
Lecture summary: Documented information is all the information needed to plan and operate your QMS. When it comes to controlling documented information, there should not...
Communication of support – Lecture 12
Lecture summary: In quality management – communication means a process or activity for exchanging effectively information between everyone included in the operation of the QMS...
