Whitepapers
MedTech quality and regulatory whitepapers
This page provides Medical Tech quality and regulatory whitepapers with practical guidance on quality, risk, design controls, and regulatory compliance for medical device and SaMD companies. The resources include detailed explanations of ISO 13485 requirements, ISO 14971 risk management practices, FDA QMSR expectations, and EU MDR/IVDR considerations, helping QA/RA professionals understand best practices and regulatory obligations across global markets.
Remote Audit
In medical device regulation, a remote audit follows the same objectives as an on-site visit: verify that the quality management system is implemented and effective....
Risk Management as ISO 14971 requires
qmsWrapper recognizes how better quality data is important for decision making. Why is it important to think about risk management as a process and how...
Quality Management System
Today the marketplace is overladen and that makes it very competitive, especially for small businesses. Quality services or products can make small businesses not only...
Supported ISO 9001 and the new clause Hail Mary Pass
qmsWrapper recognized the client's needs and specific requirements. qmsWrapper is now pleased to announce a newly added version that completely covers and supports ISO 9001:2015....
Checklist for implementing a QMS for ISO 9001-2015
ISO 9001 is a process standard for a quality management system, known worldwide. This standard is suitable for any size company or organization that wants...
Things to know before you buy qmsWrapper
A good quality management system is a must. The selection of the proper quality management system software is critical to the success of any company. Picking...
eQMS validation
Validation of software is an important and obligatory part of the process when you are using eQMS. It is a process of evaluating software product,...
Data Security
Medical device quality records carry legal and regulatory weight. A complaint investigation, a CAPA decision, a risk assessment approval, or a 21 CFR Part 11...
Project & Quality Management System
An innovative and novel approach to quality and compliance can best be expressed as management through quality compliance as opposed to quality management. Management through...
