7:45 a.m., a customer reports a defect on a lot. Where do you start?
A customer reports a defect on a delivered lot: two hours of binders for an approximate answer, or seven minutes when the batch record is written during manufacturing.
Blog
Guides and news on production, quality and compliance in healthcare.
In-depth guides on the questions that come up in audits, during lot recalls and when choosing a tool, along with the Cerebellis team's posts on the regulation of health products.
Articles
Computerized system validation (CSV) according to GAMP 5
Software categories, V-model, risk analysis and traceability matrix: how GAMP 5 structures a risk-proportionate computerized system validation.
Producing PMS and PSUR reports without rebuilding the data by hand
A PSUR links exposure, incidents, trends and actions. Why this data lives in two systems, production and quality, and how to bring it together to produce the report without re-entry.
Post-market surveillance: PMS, PSUR and vigilance under the MDR and IVDR
PMS plan, PMSR, PSUR, PMCF/PMPF, vigilance and EUDAMED: what a manufacturer must organize after placing a device on the market, depending on its class.
Production management software for medical devices: what evidence should it create?
Batch record, actual consumption, inspections, equipment, deviations and release: what production software must help you demonstrate in a medical device or IVD environment.
ISO 13485 QMS software: what it should support
A QMS is not a piece of software: what the MDR, the IVDR and ISO 13485 ask of the quality system, and how to choose which workflows to digitize first.
CAPA and non-conformities for medical devices: from deviation to effectiveness
Correction, corrective action, cause and effectiveness check: structuring a CAPA process proportionate to risk, without opening a CAPA for every deviation.
IVDR software for IVDs: production, traceability and quality under Regulation 2017/746
Classes A to D, performance evaluation, PMPF, 2027-2029 transitions, UDI and EUDAMED: what the IVDR changes for the data of an IVD manufacturer.
Equipment metrology management: the real issue starts when an instrument drifts
Calibration, verification, intervals and out-of-tolerance results: controlling measuring equipment and immediately finding the lots that may be affected.
Medical device traceability: reconstruct a lot in seconds
What ISO 13485 and the MDR require of lot traceability, the six practical requirements to meet, and a simple test to see where yours stands.
UDI labeling under the MDR: structure, formats and sources of error
The structure of the UDI, the recognized issuing entities and the points where labeling errors appear in production.
Software for regulated production: ISO 13485, MDR and 21 CFR Part 11
No software is "ISO 13485 certified": what the frameworks require concerns your records and a validation you remain responsible for.
Laboratory inventory management: reagents, consumables and expiry dates
Expiry by lot, supplier lots, quality statuses, metrology and storage conditions: the specifics that a general-purpose inventory tool handles poorly.
MES, QMS, ERP or LIMS: which software actually solves your problem?
Four categories of software that people confuse, four different questions, and a comparison table to identify the one you are missing.
Medical devices and IVDs: what if the Cyber Resilience Act affected your production?
The Cyber Resilience Act does not directly target medical devices, but it indirectly affects their production through the digital components supplied by third parties.
A finding from notified bodies, critical consequences for MedTechs, a situation you can anticipate
A 2024 survey conducted for the European Commission shows that fewer than half of the files received by MDR notified bodies are complete on receipt, and a lack of traceability is a major cause.
What is the Scaling Wall in MedTech?
The real brake on MedTech growth is not the market but the methods: without digital traceability in the QMS, growth hits a methodological wall.
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