Choosing a biomedical engineering company is a decision that shows up at every accreditation survey. The right provider keeps your equipment safe and your records complete. The wrong one leaves gaps you only discover when a surveyor asks for evidence. These eight questions will help you compare providers on what actually matters.
1. Do you test to AS/NZS 3551?
Medical electrical equipment should be tested to AS/NZS 3551, not AS/NZS 3760, which is the general test and tag standard for office and workplace appliances. Ask which standard the provider tests to, and whether their reports say so. If you’re unsure of the difference, see our guide to AS/NZS 3551 vs AS/NZS 3760.
2. Do you check performance, or only electrical safety?
An electrical safety test tells you a device won’t shock anyone. It doesn’t tell you whether a blood pressure monitor reads accurately, a defibrillator delivers the right energy or an infusion pump delivers the right volume. Ask whether performance testing and calibration are included, and against what reference.
3. Is your own test equipment calibrated?
Your results are only as good as the analysers used to produce them. A reputable provider can show current calibration certificates for their safety analysers, defibrillator analysers and other test equipment.
4. What quality system do you work under?
ISO 9001 certification shows the provider runs a documented, audited quality system, so testing is done the same way every time and records are controlled.
5. Do you hold the licences the work needs?
Some work needs more than a biomedical background. Medical gas systems are licensed work in Queensland, New South Wales and the ACT, and patient area electrical testing under AS/NZS 3003 has its own requirements. Ask for licence numbers, and check the licence covers the work being quoted. Our guide to medical gas licensing explains what to look for.
6. Are you authorised by the manufacturers of our equipment?
Manufacturer authorisation gives the provider access to service manuals, genuine parts, software and training for that brand. For complex equipment such as patient monitors, it can make the difference between a same visit repair and weeks of downtime.
7. What will our records look like?
Ask to see a sample report. Good records list every asset with a unique ID, location, test date, standard, results, pass or fail, and the next due date, and they’re easy to hand to a surveyor. Ask how failed items are reported and followed up.
8. Can you cover all our sites and work around our patients?
If you run more than one site, check the provider can cover all of them on one schedule with consistent records. Ask how they plan testing around theatre lists, resident routines or clinic hours, and how quickly they respond to breakdowns.
How Nova Biomedical Answers These Questions
- Testing to AS/NZS 3551, with performance testing and calibration, for more than 25 years.
- ISO 9001:2015 certified.
- QBCC medical gas licence in Queensland, and AS/NZS 3003 patient area testing.
- Philips Authorised Service Provider.
- Audit-ready records and PPM contracts that keep every site on one schedule.
- Servicing Queensland, New South Wales, Western Australia and New Zealand.
You can see the kinds of organisations we support on our who we work with page.
FAQ
What does a biomedical engineering company do?
A biomedical engineering company tests, calibrates, maintains and repairs medical equipment for hospitals, clinics, aged care and other healthcare facilities, and keeps the records needed for accreditation.
What standard should medical equipment be tested to in Australia?
Medical electrical equipment should be tested to AS/NZS 3551. AS/NZS 3760 is the general test and tag standard and isn’t intended for medical equipment.
Why does ISO 9001 matter when choosing a biomedical provider?
ISO 9001 certification shows the provider works under an audited quality system, so testing is consistent and records are controlled.
Talk to Nova Biomedical
Comparing providers? Contact Nova Biomedical and we’ll answer all eight questions for your facility and send you a sample report.
