Learn the principle. Practise the decision.

A device pathway depends on its intended use and jurisdiction. A quality certificate, establishment registration and product authorization answer different questions. Use the original regulator record for the precise product and scope.

Check the regulator’s recognition or harmonisation record, including any limits. A standard number without an edition and scope is an incomplete reference. ASCA participation also requires checking the laboratory’s current status.

Biocompatibility assessment considers the finished device and its contact with the body. Manufacturing, sterilisation and residuals can matter. The evidence must fit the nature and duration of contact; a raw-material certificate alone may not address the finished product.

Reprocessing must address the particular device and its instructions. Complex channels and joints can retain soil. Cleaning validation should use a relevant challenge and measure suitable residual soil; spore reduction alone is not a substitute for demonstrating cleaning.

Human-factors work connects users, use environments and interfaces. Relevant users may include patients, caregivers and staff who set up, maintain or reprocess the device. Labelling and training are part of the interface, not the whole interface.

Clinical investigations assess device safety and performance; IVD performance studies address diagnostic performance. A registry record helps locate a study, but it does not by itself establish a favourable result or authorize a product.

Use a transparent diagnostic-study report to examine the intended use, participants, test and reference standard. Reporting guidance helps reveal missing information; it does not replace critical appraisal or the applicable IVDR requirements.

Software evidence depends on the device’s functions and intended use. Use current guidance to examine lifecycle documentation and cybersecurity. An AI authorization list is a starting point: the individual record defines the authorized device and scope.

MAUDE reports can be incomplete, unverified or biased. Counts alone cannot establish incidence, compare device event rates or demonstrate causation. Read signals alongside the official alert and other evidence.

Procurement planning should connect the clinical need with technical requirements and the resources needed to use the device. Include installation, training, consumables and service when comparing options. Our cost worksheet is an editable planning model, not a price quotation.

A maintenance programme includes inspection, preventive work and corrective work. Link records to a unique asset, its use and service history. Decommissioning needs an explicit decision and documented process rather than simply deleting an inventory row.

Record the database, exact strategy, date and screening decisions. Use reporting guidance appropriate to the review and study design. A search result is a candidate source: read the full study and appraise its relevance and limitations before using its conclusions.