Device quality tends to live in SharePoint, spreadsheets, and a QMS built for pharma that never quite fits. The other option is an enterprise platform with an implementation a lean RA/QA team can't absorb. LabRelations takes a different approach. Our QMS is designed around how manufacturers actually work: design controls and DHF, risk per ISO 14971, complaints into CAPA, supplier qualification, and the training that keeps a Part 820 system inspection-ready. There's still setup, and our team is with you through it - but we've done the hard work upfront so you're running sooner, with less complexity to manage. When you run clinical investigations, CTMS sits alongside under ISO 14155 and 21 CFR Part 11.
For manufacturers heading toward 510(k), De Novo, or EU MDR, that means a quality system that holds up in an FDA inspection without a year-long implementation.
LabRelations Quality Platform is built for ISO 13485 and 21 CFR Part 820. Clinical Platform is there when you run investigations.
QMS for documents, design controls, DHF, deviations, change control, complaints, training, supplier qualification, and risk. CAPAs run from open to close in one place. A complaint opens a CAPA without a handoff between systems. When an SOP or work instruction changes, the right people get re-trained automatically. Built to stay inspection-ready under ISO 13485, 21 CFR Part 820, EU MDR, and 21 CFR Part 11.
Design history stays in the same system as the rest of quality, not a parallel folder structure. Changes to design, process, or suppliers route through impact assessment and approval, with traceability back to the DHF and the risk file. Risk management follows ISO 14971 so controls stay linked to the documents and training that implement them.
A mix of people who've worked in device quality (usually RA/QA, design quality, and post-market) backed by technical people for configuration needs inside the platform itself. They know the difference between a complaint, an NCR, and a CAPA without having to ask.
