Industry & Applied R&D
Medical Devices & Diagnostics
Development and manufacture of medical devices and in vitro diagnostics. Governed by ISO 13485 quality management, FDA design controls, EU MDR/IVDR, and — for laboratory-developed tests — CLIA and CAP requirements, with distinctive verification and validation documentation obligations.
16 pages across 3 topic areas
Laboratory Compliance & Quality
- Shelf Life and Packaging Validation for Medical Devices
How ISO 11607 packaging validation and ASTM F1980 accelerated aging combine under design controls to support a defensible medical device shelf-life cl…
- Document Control Procedure: The Six-Stage Lifecycle
How a document control procedure governs draft, review, approval, distribution, revision, and withdrawal for controlled documents in a GxP quality sys…
- Design History File (DHF): What Belongs In It, and What Doesn’t
A DHF documents how a device was designed, not how it was built or that a specific unit was built correctly. Here is what actually belongs in one, wha…
- ISO 13485 Certification: Scope, Stages and Audit Preparation
What the ISO 13485 certification process actually requires: how the scope statement on your certificate is fixed, the IAF MD 9 audit-day table your qu…
- EUDAMED: Module-by-Module Status, What Is Mandatory Now, and the SRN Registration Sequence
EUDAMED rolls out module by module. Which of the six are mandatory, which are proposed, and the actor/SRN, UDI-DI and certificate registration sequenc…
- Field Safety Corrective Action (FSCA): FSCA vs Recall vs Field Safety Notice, and the EU/US Cross-Walk
An FSCA is not a recall and a recall is not a field safety notice. The decision criteria, the conditional EU MDR Article 87 notification clocks, the A…
- IEC 62304: Software Safety Classes, Lifecycle Deliverables, and SOUP Requirements
A clause-level map of IEC 62304 Edition 1.1: what Amendment 1:2015 changed about software safety classification, which deliverables each of classes A,…
- ISO 14971: The Risk Management File, Benefit-Risk Determination, and the ISO/TR 24971 Cross-Walk
ISO 14971:2019 requires a traceable risk management file, not a risk table. What clause 4.5 must contain, how clause 7.4 and clause 8 benefit-risk det…
- 21 CFR Part 820: Subpart-by-Subpart Map and QMSR Transition Status
Part 820 is now the QMSR. A subpart-by-subpart map of where every legacy Quality System Regulation requirement went, what DMR, DHR and DHF are called …
- GxP Compliance: What GLP, GCP, GMP, and GDP Actually Require
GxP is an umbrella term for GLP, GCP, GMP, GDP, and related “Good … Practice” frameworks. This guide explains what they share, which one applies to wh…
- Cleanroom Classifications: ISO 14644-1 and the FED-STD-209E Equivalents
The full ISO 14644-1 particle-limit table for ISO Class 1-9, the legacy FED-STD-209E Class 1/10/100/1,000/10,000/100,000 equivalents, and how a class …
- CLIA Certification: Certificate Types, Complexity Categories, and Whether Your Lab Needs One
A guide to CLIA certification under 42 CFR Part 493: the five certificate types, waived/moderate/high complexity categories, and the research-lab exem…
- Computer System Validation (CSV): GAMP 5, IQ/OQ/PQ, and 21 CFR Part 11
What computer system validation actually requires for regulated laboratory systems: the GAMP 5 risk-based approach, GAMP software categories and the c…
- ISO 13485: Medical Device Quality Management Systems Explained
ISO 13485:2016 is the standalone international standard for medical-device quality management systems. A clause-by-clause walkthrough of what each req…
Clinical Research Administration
- 21 CFR: What Title 21 of the Code of Federal Regulations Covers
A routing guide to Title 21 of the Code of Federal Regulations: how CFR citations are structured, and which Part governs electronic records, informed …
