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
What is medical devices lifecycle
The Medical Device life cycle is considered a development of the product, from the very beginning to the end. What is the beginning, what is involved in...
How to do an Offsite Audits
An offsite audit is the same as an on-site QMS audit, but the auditor engages with you via technology. The Initial Preparation Prior to starting the...
Extraordinary circumstances require extraordinary measures-Offsite auditing
Certain audits of medical devices and processes are essential for MedDev companies if they want to place their product on the European market. However, audits are not used...
Basic Terms in Medical Device Industry
We can’t emphasize enough how important is to understand the language of medical devices. To meet the requirements and the Regulations it’s essential to understand...
Quality Manual or Workflow Processes? What should I establish first?
So, what documentation hierarchy should we adopt? It turns out that this question is a classic for a reason. People have been asking it for...
QMS Manager role in MedDev industry
QMS manager role in MedDev industry: focus on quality processesQMS manager responsibilities in MedDev industryThe responsibilities may include the followingQMS manager requirementsKey Questions About the...
Interview with one of qmsWrapper’s successful User
qmsWrapper has many Users who have been renewing their license for several years now, showing how satisfied they are with this QMS software. qmsWrapper is intended for...
Documents in a Paperless Office, Find a Needle in the Haystack
The QMS documentation – especially for a complex project – can be endless and impenetrable. All of us are familiar with the pain of trying...
Balancing Priorities when everything is #1
Ballance as a secret to success Every given task needs to have a clear priority. In the medical device industry, when everything seems so important,...
