qmsWrapper Blog
How Companies Are Transforming Their Risk Assessment Processes for Better Results
Optimizing Medical Device Risk Management for Efficiency, Accuracy, and Compliance
One of the persistent challenges in medical device development is ensuring that risk assessment processes are both compliant and practically useful. While standards like ISO 14971 provide the framework, implementation in real-world scenarios often reveals inefficiencies — from inconsistent documentation to siloed decision-making.
Companies are now rethinking...
How to Apply AI Risk Prompts to Real-World Medical Device Development
Learn how to turn AI risk prompts into real-world medical device strategies using hazard logs, ISO 14971 workflows, and practical development scenarios.
ISO 9001 implementation: Mandatory documents and records
Find out what are the mandatory documents and records for the successful implementation of ISO 9001 in our article.
ISO 13485 implementation: Mandatory documents and records
Preparation of the QMS documentation is based on the organizational needs, and it is crucial for an efficient QMS.
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.
Validation efforts
If you want to use secured and reliable software, this is what you must know about QMS software validation.
Remote audits – what are the limits?
A virtual audit is a method of conducting an audit distantly, using electronic means such as videoconferencing, email, and telephone to acquire audit evidence.
Benefits of remote auditing
Remote audits can have many benefits in terms of efficiency, access to competencies, increased reach and risk mitigation. Check out what the benefits might be.
Do remote audits becoming 'new normal'?
Remote audits refer to the use of information and communication technology for collecting information, questioning audited personnel, etc.
Continual Improvement and Nonconformity and corrective action – Lecture 24
Improvement means, in a way, finding the parameters that affect the realization of goals and submitting them to change.
Management review – Lecture 23
It is one of the methods dictated by the ISO 9001 standard for monitoring the QMS and evaluating its performances and effectiveness.
Internal audit – Lecture 22
The internal audit is one instrument for self-review of whether requirements are achieved. More in our next lesson.
Monitoring measurement, analysis, and evaluation – Lecture 21
This part of the ISO 9001:2015 is critical for assessment of the performance of your QMS. Find out more about monitoring, measurement, etc.
Control of Nonconforming Outputs – Lecture 20
Controlling the nonconforming outputs will allow you to minimize their effect, map the problem, and track down the root cause – learn more with qmsWrapper.
Release of products and services – Lecture 19
Release of the product or services is about verification that the product and service requirements have been met according to customer requirements.
Production and service provision – Lecture 18
Learn how to control, identify and preserve production and service provision according to ISO 9001:2015, with qmsWrapper.
Control of externally provided processes, products, and services – Lecture 17
It all varies widely depending on the nature of the processes, products, and services.
Design and Development of products and services – Lecture 16
ISO 9001 standard requires you to control the entire design and development cycle - explained step by step by qmsWrapper through its lectures.
Requirements for products and services – Lecture 15
This chapter is the point to determine exactly what your product's specifications are, and to evaluate them later, to make them clear, documented, etc.
Operational planning and control – Lecture 14
The ISO 9001 requires practical actions for planning and control so you can conduct it through the processes. It includes a Quality plan as well – learn more.
Documented information – Lecture 13
Documented information is the key element of your QMS and it has to be controlled – why and how – find out here. ISO 9001 lectures by qmsWrapper.
Communication of support – Lecture 12
Efficient flow of data, information, and knowledge shared between as requirements by ISO 9001.
Awareness of support in ISO 9001 – Lecture 11
Awareness of the QMS increases the motivation and devotion of employees in your company – emphasizes ISO 9001, clarifies qmsWrapper.
Top 5 trends in the MedDev industry for 2021
Follow trends related to MedDev industry with qmsWrapper. 5 fields are innovative and impactful as technology and healthcare are developing daily.
Competence in Support of ISO 9001 – Lecture 10
Employees' competency is crucial for your successfully produced product or service. What is the importance of training, education, and qualification?