Medical device quality management becomes more demanding as a company grows. Controlled documents, forms, approvals, and training provide the foundation. As quality events become connected with CAPA, risk, suppliers, changes, and technical documentation, teams need workflows that keep those connections visible. They need to show…
There is a point in almost every medical-device startup when the quality management system stops being something the team can tolerate and becomes something the company must actively control. In the beginning, paper can work. Shared drives can work. A few spreadsheets can work. Everyone…
A connected QMS platform that grows with your company Medical-device companies do not all need the same QMS on day one. Some teams are still moving from paper forms, Word templates and spreadsheet logs into controlled records. Others are managing CAPA, change control, risk, training,…
qmsWrapper 10.2 is now live, introducing advanced QMS change impact analysis alongside major improvements across AI, Change Management, Forms, Processes, and Technical File control. At the center of this release is Wrapper-Mapper: an AI engine that analyzes change impact across your Technical File and the…
Quality management was never meant to be a chase — it was meant to be clarity. Yet somewhere between paperless initiatives, scattered tools, and endless spreadsheets, that clarity disappeared. With this release, qmsWrapper becomes an AI-powered QMS for MedTech — built to eliminate silos and…
The new version of qmsWrapper is updated in December 2019. We were still shaking from a disastrous ISO audit. Joe, the perennial QMS manager from Jurassic times, just have been fired. Even though he liked pushing the paper-based system, a medical device company has too many…
We are pleased to announce the release of the new team managing tool – My Team, in the Project Management Module for qmsWrapper. Projects are about teams, but the biggest project of all is managing your team. Announcing “My Team”, the newest element of qmsWrapper. “My…
Buying an electronic QMS is not the same as buying software. For a medical device company operating under ISO 13485, FDA QMSR, or EU MDR, the system you select becomes part of your quality infrastructure and, by extension, part of your regulatory record. A document…
