QMSR transition Feb 2026. ISO 13485 alignment gaps. Notified Body findings. CAPA backlogs. A weak QMS doesn't just fail audits — it stalls your next submission.
The objective is developing a Quality Management System that operates within your facility-not just on paper. Auditors can easily distinguish between the two.
Our solution
End-to-end QMS build, audit, and remediation. We implement QMSR + ISO 13485 + MDSAP-ready systems sized for your stage, not Fortune-100 bloat.
We will develop or enhance a "fit for purpose" Quality Systems compliant to QMSR 2026 and ISO 13485:2016 or assess gaps in your current system - so that when you go through an audit, your documents will be ready and organized in a manner that is useable and accessible to you.
Process
How we run this engagement.
Gap assessment & risk-based remediation plan
Procedure & template build (lean)
Training & roll-out
Internal audit program
External audit / inspection defence
ISO 13485 / QMSR builds, remediations and harmonisation.
How we help
Pragmatic QMS architecture aligned to ISO 13485:2016, FDA QMSR (2026), MDSAP, and your actual operating model.
