Avoiding Failure: Top Risks in Medical Equipment Calibration
In the medical industry, precision isn’t just a preference—it’s a necessity. Calibration programs ensure that life-saving equipment manufacturers operate within strict accuracy standards, and failing to manage calibration programs effectively can lead to serious consequences, from regulatory non-compliance to compromised patient safety.
At SIMCO Electronics, we specialize in helping healthcare and medical device manufacturers mitigate calibration risks while maintaining efficiency and cost-effectiveness. Below, we summarize the top risks associated with medical equipment calibration programs and how we help organizations stay compliant and operationally sound.
- Risk of Non-Compliance with Regulatory Standards
Medical devices must meet regulatory requirements set by agencies such as the FDA, ISO 17025, and other global healthcare standards organizations. Failing to comply can lead to audit findings, fines, product recalls, or even production shutdowns.
To avoid this risk, organizations should implement a compliance-driven calibration program that ensures all equipment is calibrated according to manufacturer specifications and regulatory guidelines. Industry leaders partner with an accredited calibration provider that follows ISO 17025 standards. Leveraging calibration management software helps track calibration status, maintain records, and ensure compliance ahead of audits.
SIMCO partners with some of the world’s leading medical device manufacturers and has seen firsthand how compliance missteps can lead to costly disruptions. In regulated environments, a single audit finding can cost upwards of $100K, making proactive compliance management critical. By leveraging structured Program Health Reviews (PHRs) with our industry specific account managers, we help our clients regularly assess program effectiveness, identify at-risk areas, and implement corrective actions before they become major issues.
- Inconsistent Calibration Intervals
Over-calibrating equipment can lead to unnecessary downtime and increased costs, while under-calibrating can result in measurement drift, leading to inaccurate diagnostics and potential patient risks.
A data-driven calibration frequency approach helps optimize intervals based on equipment failure rates and historical performance rather than rigid calendar-based schedules. AI-driven tools can analyze historical calibration data to determine the optimal recalibration frequency for each piece of equipment. Conducting periodic reviews ensures calibration schedules align with operational needs and regulatory requirements.
At SIMCO, we take an advanced approach to interval optimization, using Lean Six Sigma methodologies to prevent unnecessary calibrations while ensuring compliance. In one case, adjusting a customer’s calibration schedule from 12 to 16 months—without sacrificing accuracy—led to over $500K in annual cost savings while maintaining compliance. Our customers benefit from customized calibration strategies that reduce waste and improve efficiency.
- Poor Documentation and Record Keeping
A lack of proper documentation can result in failed audits, regulatory penalties, and operational disruptions. Without a centralized system, tracking calibration history and proving compliance becomes difficult.
Digitizing calibration records with calibration management software automates documentation and retrieval, reducing manual errors. Ensuring traceability by keeping all calibration certificates linked to national or international standards provides full accountability. Maintaining organized and accessible records allows for real-time audit readiness, minimizing compliance risks.
SIMCO’s CERDAAC calibration management software was designed to facilitate documentation best practices and streamline compliance tracking.
Many calibration providers fail to offer fully integrated digital solutions, leaving customers scrambling during audits. CERDAAC allows customers to generate real-time compliance reports, track instrument status, and ensure that all accredited calibration records are traceable to national and international standards. This proactive documentation approach reduces the risk of costly regulatory citations and operational slowdowns.
- Using Unqualified Calibration Providers
Not all calibration providers follow strict quality and regulatory standards. Some lack proper accreditation, experience, or equipment necessary for precise calibration of medical devices, which can lead to inaccurate results or failed audits.
Organizations should verify that their calibration provider holds ISO 17025 accreditation to meet international standards for technical competence and measurement accuracy. Assessing provider expertise ensures they have experience in calibrating specific equipment and working within regulated industries. Prioritizing a calibration partner over a basic vendor adds value through compliance insights, cost-saving strategies, and continuous support.
One of the most overlooked risks in calibration is selecting a provider based solely on cost. SIMCO has seen cases where companies switched to low-cost providers only to face audit failures due to improperly calibrated instruments.
Our approach extends beyond simple calibration and final inspection—we implement a comprehensive quality control process to verify that every instrument meets compliance standards and performance requirements before being returned to the customer.
Additionally, we conduct ongoing technician performance monitoring, identifying and addressing any issues before they impact our customers.
- Failure to Address Out-of-Tolerance (OOT) Events
When equipment is found to be out of tolerance, past measurements may have been inaccurate, potentially affecting product quality, diagnostic results, and ultimately patient health. Without a proper process in place, organizations risk using unreliable equipment.
Establishing clear OOT protocols ensures a structured action plan for investigating, documenting, and correcting occurrences. Conducting root cause analysis helps identify why an instrument failed calibration to prevent recurrence. Implementing preventive measures such as regular maintenance, improved storage conditions, and proper handling procedures minimizes OOT events.
OOT events are not just a compliance risk—they can have serious financial and reputational consequences. In one case, a major medical device company discovered an OOT rate of 15% due to poor calibration oversight, leading to a federal investigation and major disruptions in production.
At SIMCOSIMCO, we work with customers to implement robust OOT tracking and root cause analysis, using data-driven insights to predict and prevent failures before they occur. Our customers benefit from not only resolving current OOTevents, but also from long-term solutions that enhance equipment reliability.
Proactively Managing Calibration Risks
Managing a medical equipment manufacturing calibration program requires a proactive approach to compliance, scheduling, documentation, provider selection, and out-of-tolerance events. By addressing risks, manufacturers can maintain operational excellence, regulatory compliance, and—most importantly—patient safety.
With 60 years of experience serving the medical device industry, SIMCO Electronics has developed tailored calibration solutions that go beyond simple compliance. Our nationwide network of over 20 labs, advanced digital tools, and deep expertise in regulated industries make SIMCO the trusted partner for organizations looking to reduce risk and improve operational efficiency.
Is your calibration program audit-ready? Request a quote today!