Who We Serve: Medical Equipment
Electromedical and Capital Equipment
Electromedical equipment keeps working, and keeps generating quality records, long after it ships. Installation, preventive maintenance, repairs and field upgrades are all part of the quality system, and they are where capital equipment makers most often fall behind. We help find those gaps across the factory and the field.
Standards and Regulations to Know
- IEC 60601-1Basic Safety and Essential Performance of Medical Electrical Equipment
- IEC 60601-1-2Electromagnetic Compatibility of Medical Electrical Equipment
- IEC 60601-1-8Alarm Systems in Medical Electrical Equipment
- IEC 62366-1Usability Engineering for Medical Devices
- IEC 62304Medical Device Software Lifecycle Processes
- ISO 14971Risk Management for Medical Devices
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- 21 CFR Part 806Reports of Corrections and Removals
Typical Regulatory Exposure
The IEC 60601-1 family covers basic safety and essential performance of medical electrical equipment, with collateral standards for electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6), alarm systems (IEC 60601-1-8) and the home healthcare environment (IEC 60601-1-11), plus particular standards for specific equipment types. IEC 62366-1 covers the usability engineering process, and IEC 62304 applies to embedded software.
Essential performance is defined by the manufacturer through risk management under ISO 14971, so safety testing is only as good as the risk analysis that scoped it. Auditors look for a clear line from hazards to essential performance to test results, and for a reassessment whenever a component, software version or applicable standard changes.
Installation and servicing are quality system activities. The QMSR's FDA-specific record requirements in 820.35 include servicing records, and service reports often contain complaints that must be evaluated as such. Field upgrades, spare parts and refurbished assemblies all need change control and configuration records that say exactly what is installed at each site.
Where Audits Find Gaps
- 01
Service Reports Not Evaluated as Complaints
Field service tickets describe failures and malfunctions, but nobody reviews them for complaints or reportable events, so they never reach the complaint file.
- 02
Installed Base Configuration Unknown
The firm cannot say which hardware revision and software version runs at each customer site, which makes any field correction slow and its scope uncertain.
- 03
Installation Without Documented Acceptance
Installations are completed and signed off by the customer, but the acceptance tests the installation procedure requires are not recorded.
- 04
Field Engineers Trained Informally
Service engineers learn on the job, with no training records tied to the specific models and procedures they work on.
- 05
Spare and Refurbished Parts Uncontrolled
Parts returned from the field are reused without documented inspection, testing or traceability to the units they go into.
- 06
Safety Testing Not Reassessed After Changes
Components and firmware changed after the safety test report was issued, with no documented assessment of whether the testing still applies.
Relevant Standards and Regulations
- IEC 60601-1Basic Safety and Essential Performance of Medical Electrical Equipment
- IEC 60601-1-2Electromagnetic Compatibility of Medical Electrical Equipment
- IEC 60601-1-8Alarm Systems in Medical Electrical Equipment
- IEC 62366-1Usability Engineering for Medical Devices
- IEC 62304Medical Device Software Lifecycle Processes
- ISO 14971Risk Management for Medical Devices
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- 21 CFR Part 806Reports of Corrections and Removals
Relevant Services
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
CAPA System Remediation
Fixing a CAPA system auditors keep citing: the procedure, the records, root cause, effectiveness and backlog.
Internal Audit Program
A risk-based internal audit program, run by your team or our advisors, with reports written for FDA to read.
Audits and Inspections You May Face
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
ISO 13485 Surveillance Audit
The periodic audits, at least annually, that support continued ISO 13485 certification between renewals.
MDSAP Audit
One audit by a recognized auditing organization that covers several participating regulators, including FDA.
Questions
Do service calls count as complaints?
A service report describing a failure of the device to meet its specifications or perform as intended is typically a complaint and needs to be handled as one. The dependable approach is to review every service record for that question and record the answer.
Is an IEC 60601-1 test report enough for an auditor?
It shows the device met the standard as tested. Auditors will also ask how essential performance was defined through risk management, and whether changes since the report were assessed. A report on an earlier revision with no such assessment is a common gap.
Can the platform hold our field service records?
Yes. Upload service reports in whatever format your field team uses. The AI-assisted first pass flags reports that read like complaints or possible reportable events, and an advisor confirms each one before it becomes a finding.
Electromedical and Capital Equipment
Get an Advisor's View of Your Quality System
Tell us about your devices and the audit or inspection ahead, and an advisor will scope an assessment for your kind of product. Please don't send confidential documents yet: secure upload is set up after onboarding.
