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
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...
Awareness of support in ISO 9001 – Lecture 11
Lecture summary: The implementation of awareness procedures should be a priority of your business Make the employee aware of the aspects and hazards, and the...
Competence in Support of ISO 9001 – Lecture 10
Lecture summary: The company has to decide what particular competencies are needed to perform his/her job correctly Once you determine the competence, you will see...
Top 5 trends in the MedDev industry for 2021
With the aim to keep track of where healthcare technology is going, studying tech trends is essential. The MedDev industry is always looking for alternative...
What is Resource Management in the medical device world – Lesson 8
As a requirement within ISO 13485, the management must ensure that adequate resources are available to perform continuous work by the organization. Providing resources can...
Work environment and contamination control according to ISO 13485 – Lesson 9
Work environment and contamination control are important and critical for effective and compliant medical device business run. Definition of the Working Environment Work conditions and...
