Everything BiomedRx publishes on biomedical equipment certification in one place: the full service overview, the related services we provide, and the locations we cover.
This is the index for biomedical equipment certification. If you already know which service you need, go straight to it below; if not, the full overview explains what each one covers.
The certificate is the deliverable, so it has to be written to be read by someone who was not there — an inspector, a risk manager, a plaintiff's expert. Vague certificates fail exactly when they are needed most.
Findings are reported plainly, including the ones that mean a device should be taken out of service.
Certification is a formal statement that a device meets a defined standard on a defined date, backed by measurements someone else can check. It is not a sticker. The document has to name the standard, the method, the equipment used and its own traceability, or it will not survive scrutiny.
Scope is written down before the work begins, including what is excluded. Most disputes about equipment service are really disputes about scope that nobody put in writing.
The documentation is not administrative overhead; it is the deliverable that outlives the visit. When an inspector, an insurer or a lawyer asks what condition a device was in on a particular date, the record is the entire answer, and a facility either has it or does not.
There is no charge for the conversation that establishes whether you need this service at all.
Current developments in biomedical equipment certification, with sources for further reading.
Primary regulations and standards referenced on this page. Where a standard is published commercially it is named in full rather than linked to a copy.
