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
Software as a medical device – life cycle
The life cycle of the medical device is a development process of the product, from its beginning to the end. The same applies to software that can represent a medical...
Validation efforts
When an eQMS is implemented in a medical device company, such software must be validated. It should be ensured that the system is working and...
Remote audits – what are the limits?
A remote audit, also known as virtual audit, is the method of conducting an audit distantly, using electronic means such as videoconferencing, email, and telephone to acquire...
Benefits of remote auditing
Remote audits may have many benefits when it comes to efficiency, access to competence, increased reach and mitigating risks. But companies have to use it in the right...
Do remote audits becoming ‘new normal’?
Audits are used for a variety of reasons, including assessing compliance with standards and regulations, adherence to requirements and specifications, evaluating process and system performance, evaluating...
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...
