How to Start a Biomedical Equipment Repair Business: A Practical Checklist
Short answer: most independent biomed shops start with one or two experienced BMETs, a clear niche (general biomed, imaging, lab, or a family of devices), calibrated test equipment, the insurance hospitals ask for, and one or two anchor customers. In the US, a company that only services devices does not register with FDA the way a manufacturer does, but FDA's 2024 guidance says work that significantly changes a device's performance, safety specifications or intended use is remanufacturing, which brings manufacturer obligations. Decide your model, get the paperwork hospitals will ask for ready before the first sales call, and price from your real costs.
This is a checklist, not a business plan template. It is written for a BMET thinking about going independent, or a small shop formalising what it already does.
1. Choose the business you are actually starting
| Decision | Options | What it changes |
|---|---|---|
| Where the work happens | Field service at customer sites, depot repair on your bench, or both | Vans and travel time versus shop space, shipping and loaners. See depot vs field service. |
| What you service | General biomed, imaging, lab, sterilization, or one device family | Training, test equipment, parts access and state requirements (imaging especially) |
| Who you sell to | Hospitals, surgery centers, clinics, physician offices, dental, veterinary, dealers | Contract size, paperwork, payment terms and how long sales take |
| How you charge | Time and materials, PM-only contracts, full-service contracts | Cash flow and how much risk you carry. See how to price a service contract. |
2. People and credentials
- Experience you can document. Hospitals and their surveyors care that the people servicing equipment are qualified. CMS says that applies to contractors as well as employees.
- Professional certification. The AAMI Certification Institute runs the CBET credential (and CRES and CLES for radiology and lab specialists). It is not a legal requirement, but it is a common way to show competence.
- OEM service training for the systems you plan to support, with certificates on file.
- A qualifications file per technician: training records, certificates, OEM courses. You will be asked for it.
3. Test equipment
Buy, or rent at first, the instruments your work needs, and put each one on a calibration schedule from day one. A typical general biomed list:
- Electrical safety analyzer
- Defibrillator / pacemaker analyzer
- Infusion device analyzer
- Patient simulators: ECG, NIBP, SpO2
- Electrosurgical analyzer, if you service ESUs
- Gas flow / ventilator analyzer, if you service respiratory equipment
- Pressure meter, digital multimeter, thermometer, tachometer
Keep every calibration certificate. A hospital may ask for them during a survey. See test equipment calibration tracking.
4. Regulation: what applies to a service company
- FDA: servicing vs remanufacturing. FDA's final guidance Remanufacturing of Medical Devices (May 2024) separates the two. Restoring a device to its original specifications is servicing. Work that significantly changes its performance or safety specifications, or its intended use, is remanufacturing, and remanufacturers carry manufacturer obligations such as registration and listing and quality system requirements. Read the guidance and its flow chart before you do anything beyond restoring to OEM spec.
- State requirements for imaging. Many states require companies that install or service x-ray and other radiation-producing equipment to register with the state radiation control program. Check each state you will work in.
- Your customers' rules become your rules. Hospitals have to show surveyors that equipment is maintained to the manufacturer's recommendations or a documented AEM program. Your records are their evidence. See what CMS and Joint Commission surveyors expect.
- ISO 13485 certification is optional. Some shops pursue it to win larger contracts. It is a quality-system decision, not a legal requirement for servicing.
This is general information, not legal advice. Talk to a regulatory adviser about your specific services.
5. Insurance
Hospitals usually ask for a certificate of insurance before you start, and they set the minimums. Expect to be asked for general liability, professional liability (errors and omissions), commercial auto if you drive to sites, and workers' compensation once you have employees. Ask a broker who covers medical equipment service companies; the limits a hospital requires vary.
6. The paperwork hospitals ask for
Have these ready before your first sales call:
- W-9 and certificate of insurance
- Technician qualifications files
- A sample service report for a device like theirs, with electrical safety readings on it (template here)
- Your PM procedures and where their intervals come from
- Test equipment list with calibration dates
- Response times and after-hours coverage you can actually deliver
- Registration with the hospital's vendor credentialing program, if it uses one
7. Parts and service information
Set up accounts with OEMs and parts suppliers early, and find out which manufacturers will sell you service manuals, parts and training. Access varies widely by manufacturer and device. Track every part against the work order it went into from the start; it is what your invoice and your device history are built on.
8. Pricing
Work out your fully loaded hourly cost (wages, taxes, benefits, vehicle, test equipment, insurance, software, unbilled time) before you quote anything. Price time-and-materials work from that, and build contracts from the hours each device actually takes. Two guides: pricing strategy for a biomed repair shop and how to price a service contract.
9. Systems
A spreadsheet and an accounting package will carry a one-person shop for a while. The first contract with a few hundred devices on PM is usually when it stops working: you need one record per device, PMs that schedule themselves, reports the customer can file, and invoices from the work done. See biomed CMMS vs spreadsheets.
Your first 90 days
- Form the company, open a business bank account, set up accounting.
- Buy or rent test equipment; get it calibrated; file the certificates.
- Bind insurance; get a certificate template from your broker.
- Write PM and repair procedures for the devices you will service first.
- Build a sample service report and a qualifications file.
- Price your services from your loaded cost.
- Sign one anchor customer; inventory their equipment on the first visit.
- Put the inventory and PM schedule into a system that will still work at ten customers.
Where Bravio fits
Bravio is CMMS and field service software built for independent biomed shops. It holds one record per device across every customer, generates PM work orders from each device's interval, gives technicians an offline iOS and Android app, and turns a closed job into a branded, signed, ISO 13485-aligned service report and an invoice. It is free to start, and we migrate your first customer's equipment list for you. Get started free or book a 30-minute demo.
Frequently asked questions
Do I need FDA registration to start a biomedical equipment repair business?
Not for servicing alone. FDA's 2024 guidance on remanufacturing distinguishes servicing, which restores a device to its original specifications, from remanufacturing, which significantly changes its performance, safety specifications or intended use. Remanufacturers carry manufacturer obligations such as establishment registration and listing. Check the guidance and get regulatory advice for your specific services.
Do biomed technicians need a license or certification?
There is generally no federal license for biomedical equipment technicians. Certification such as AAMI's CBET is voluntary but widely used to show competence, and hospitals must be able to show that contractors servicing their equipment are qualified. Some states regulate companies that install or service x-ray and other radiation-producing equipment.
What insurance does a biomedical repair business need?
Hospitals commonly ask for general liability and professional liability (errors and omissions) cover, plus commercial auto if you drive to sites and workers' compensation once you employ people. Each hospital sets its own minimum limits, so ask a broker familiar with medical equipment service companies.
What test equipment does a new biomed shop need?
It depends on what you service. A general biomed shop usually needs an electrical safety analyzer, a defibrillator analyzer, an infusion device analyzer and patient simulators for ECG, NIBP and SpO2, plus meters. Each instrument needs a calibration schedule and certificates on file.
Do I need ISO 13485 certification to start?
No. ISO 13485 certification is not a legal requirement for servicing medical equipment in the US. Some independent service organizations pursue it to compete for larger contracts.