Resources
Guides for medical device teams
Plain-language explainers on regulatory submissions, quality systems, device identification and clinical evidence — written for the people who have to do the work, and linked to the Qevatrix app that handles it.
2 guides
Regulatory & submissions
RegulatoryOS
510(k) submission guide
How premarket notification works: predicates, substantial equivalence, and what a submission has to contain.
Read the guide →RegulatoryOS
Medical device classification
FDA classes and EU MDR rules explained, with how classification drives your route to market.
Read the guide →8 guides
Quality systems
QualityOS
FDA QMSR transition guide
What changes as 21 CFR Part 820 aligns with ISO 13485:2016, and how to prepare your quality system.
Read the guide →QualityOS
ISO 13485 in 2026
What is being worked on in the standard, what stays the same, and what to plan for.
Read the guide →QualityOS
Medical device quality management system
The processes a device QMS needs, how they connect, and a practical order to build them in.
Read the guide →QualityOS
Design controls
User needs, inputs, outputs, verification, validation and the design history file, in plain terms.
Read the guide →QualityOS
What is GxP?
GLP, GCP and GMP in plain language — which GxP applies to each activity and what compliance asks of you.
Read the guide →QualityOS
21 CFR Part 11 explained
Electronic records and electronic signatures under FDA Part 11, and a practical path to compliance.
Read the guide →QualityOS
Good documentation practices
What a trustworthy record looks like, ALCOA+ data integrity, and habits that keep records audit-ready.
Read the guide →QualityOS
Design history file (DHF)
What a DHF contains, how it differs from the DMR and DHR, and how to keep it complete from day one.
Read the guide →2 guides
Clinical & evidence
These guides summarise publicly available regulatory material and are for general information only. They are not regulatory advice — always confirm requirements against the current text from FDA, the EU MDR and the relevant standards.