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
Continual Improvement and Nonconformity and corrective action – Lecture 24
Lecture summary: You must determine and select improvements and then put the action in place to meet customer’s requirements and enhance any customer satisfaction You...
Management review – Lecture 23
Lecture summary: Management review is a formal, structured meeting that involves top management Management review meeting minutes, agenda, program, and presentations should be retained as...
Internal audit – Lecture 22
Lecture summary: The internal audit is one instrument for self-review of whether requirements are achieved Specify the responsible parties that will participate in the audit...
Monitoring measurement, analysis, and evaluation – Lecture 21
Lecture summary: Measurement, monitoring, analysis, and evaluation are critical for the assessment of the performance of your QMS The activities of monitoring and measuring generate...
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...
