Short Training Videos

Design Development Plan for Medical Devices

This short training explains why the Design and Development Plan is one of the first key documents in medical device development and how it supports compliant design control under ISO 13485, FDA expectations, and the EU MDR. It outlines what should typically be included in the plan, such as development stages, deliverables, roles and responsibilities, design reviews, verification and validation strategy, interfaces, and outsourced development activities. Trainees will learn: How to structure a Design and Development Plan, why it should be treated as a living document, and why a simple Gantt chart is not sufficient to meet regulatory expectations.

Tailored QMS in 6 Weeks

An early-stage wearable device company needed to tailor their existing ISO 13485 QMS without hiring a dedicated RA/QA team. We transformed the QMS to a lean QMS that passed audit and reduced ongoing compliance workload.

From Confusion to Confidence

A founder-led team was overwhelmed by EU MDR requirements. Our team provided hands-on guidance, helping them define their classification, design a compliance strategy, and avoid 9+ months of wasted effort on the wrong documentation path.