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.
Efficient Team Communication
In regulated medical device organizations, communication is not simply a coordination tool. It is a quality record. ISO 13485 section 5.5.3 requires top management to...
Process Engine: A Comprehensive Guide
ISO 13485 clause 4.1 requires manufacturers to do more than list their quality procedures. It requires identifying each process that affects product conformity, mapping the...
Introduction to Dashboard
Quality managers in medical device companies spend a large part of their day chasing status information that lives in different places. Open CAPAs in one...
Users Roles
In a medical device quality system, who can view, edit, approve, and sign records is a regulated decision, not just an IT setting. FDA 21...
Set Up Your Profile
In a regulated quality management system, every user account is a compliance record. ISO 13485 clause 6.2 requires organizations to document the competence of personnel...
qmsWrapper with Jira integration
Software development teams building medical devices or SaMD commonly run two separate systems: Jira for sprint planning, issue tracking, and defect management, and a QMS...
Implementation agenda for setting up the QMS
Setting up a QMS for medical device development is not a single project decision. It is a sequence. ISO 13485:2016, FDA 21 CFR Part 820,...
Forms in qmsWrapper
Forms are the most basic record-creating instrument in a quality management system. A non-conformance report, a training completion record, a supplier qualification checklist, a corrective...
qmsWrapper Best Practices – Document Management
Document management is where a medical device quality system either stays audit-ready or slowly falls apart. ISO 13485:2016 Clause 4.2.3 requires controlled documents, Clause 4.2.4...
