Guide
What is GxP? A plain-language guide for medical devices
GxP is shorthand for the family of 'good practice' regulations that govern regulated life-sciences work — the x stands for the discipline in question. For a medical device company it usually means GLP, GCP and GMP: how you run non-clinical testing, clinical studies and production so regulators can trust your records.
The main GxPs
Which 'x' applies to you
GLP — good laboratory practice
Governs non-clinical safety testing, such as biocompatibility and preclinical studies. Key expectations: a defined study plan, named responsible personnel, and raw data retained so the study can be reconstructed.
GCP — good clinical practice
Governs clinical investigations. For devices, ISO 14155 is the recognised GCP standard in the EU and is widely used elsewhere. It covers ethics approval, informed consent, monitoring and safety reporting.
GMP — good manufacturing practice
Governs production and quality. For medical devices, the FDA's QMSR (21 CFR Part 820, aligned with ISO 13485) and the EU MDR's quality system requirements are the device-specific forms of GMP.
Where software fits
Computerised systems used in GxP activities are expected to be validated and controlled. In the US that expectation is expressed through 21 CFR Part 11 for electronic records and signatures; in the EU through Annex 11 and data-integrity principles.
In practice
What GxP compliance actually asks of you
- 1Know which GxPs apply to each activity — a single device programme can span GLP testing, a GCP study and GMP production.
- 2Write procedures for each controlled activity, train the people who perform them, and keep the training records.
- 3Record what actually happened: dated, attributable records that a reviewer can follow end to end.
- 4Control the systems that hold those records — access, audit trails, and reliable copies.
- 5Self-check regularly; GxP is judged on evidence, not intention, and gaps compound over time.
Where Qevatrix fits
GxP-ready records without the spreadsheet overhead
QualityOS runs your quality system on GxP-aware foundations: controlled documents, training records, validated change control and Part 11-style electronic signatures, so the records behind your GLP, GCP and GMP activities stay review-ready.
More guides
See all guidesQualityOS
FDA QMSR transition guide
What changes as 21 CFR Part 820 aligns with ISO 13485:2016, and how to prepare your quality system.
QualityOS
ISO 13485 in 2026
What is being worked on in the standard, what stays the same, and what to plan for.
QualityOS
Medical device quality management system
The processes a device QMS needs, how they connect, and a practical order to build them in.
This guide is an orientation, not regulatory advice. The scope and details of GxP requirements depend on your market and product; confirm them against the FDA QMSR, EU MDR, ISO 14155 and the regulations that apply to you.