Medical Device Maintenance
As a developer and manufacturer of three FDA-cleared steam sterilizers, we understand the need for equipment reliability and readiness and provide a team with the expertise to reduce the stress and complexities of having your equipment serviced and maintained.
Our engineers and technicians provide excellent support in troubleshooting, repairs, calibrations, tests/validations, and preventive maintenance. In addition, after service, we can perform all required operational and performance qualifications as the original equipment manufacturers’ (OEMs’) require.
Examples of How FDI Adds Value and Reduces Cost:
- Initial component evaluation to determine status of equipment
- Reliability Centered Maintenance analysis to understand functions, functional failures, failure modes, and consequences to inform the appropriate maintenance interventions to ensure availability and reliability meet expected levels
- Root Cause Failure Analysis to apply a systematic technique to understand the true cause of failure to implement corrective actions
- Cost tracking for each repair to aid in decision making for replacing old or unreliable equipment
- FDA-related field correction oversight to proactively manage medical device recall efforts within our quality assurance team to ensure timely and correct installation, testing, and validation of upgrades and corrections
- Operator training as necessary to ensure safe and reliable operation of your equipment
- Inventory control to hold your devices safely in inventory at our 90,000 sq. ft., FDA-registered facility and provide service/maintenance as needed