Overview:
For a cardiovascular medical device manufacturer, calibration reliability is critical to maintaining production readiness, quality confidence, and regulatory control. The company develops technologies used in complex clinical procedures, where product quality and operational discipline directly support patient care.
As the organization continued to grow, its existing calibration model became harder to manage. The team was working with multiple suppliers, facing inconsistent turnaround times, and dealing with missing calibration certificates. Some equipment was essential to production, while other assets were inline or too large to leave the facility, making onsite support an important requirement.
The company selected SIMCO to provide calibration and repair support, including monthly onsite service, local turnaround capability, stronger documentation control through CERDAAC, and a path to consolidate suppliers over time.
The Challenge:
The customer’s calibration process had become increasingly difficult to manage. Their current supplier had lost calibration certificates and was unable to locate them, creating concerns around documentation validity, audit readiness, and quality system control.
Turnaround times for offsite and in-lab calibrations were inconsistent, and communication issues made it harder for internal teams to plan work confidently. For a regulated medical device manufacturing environment, these issues created meaningful risk.
Missing certificates can affect audit readiness and confidence in quality records. Delayed calibrations can disrupt production schedules. Poor communication can force operations and quality teams to spend time chasing updates instead of keeping work moving.
The customer needed a calibration partner that could provide:
- Monthly onsite calibration support
- Fast local turnaround when equipment had to leave the facility
- Better communication and service coordination
- Reliable access to calibration certificates and documentation
- Support for items that were inline, too large to move, or essential to production
- A path to consolidate calibration suppliers over time
The initial engagement was designed to prove SIMCO’s service model before expanding into a larger implementation.
The Solution:
SIMCO worked with the customer to build a calibration support model aligned to the needs of a growing, regulated production environment.
Rather than providing basic calibration services alone, SIMCO combined local support, documentation control through CERDAAC, and a scalable service model to help keep production-critical assets available while strengthening calibration management.
SIMCO’s approach focused on three priorities:
- Provide Monthly Onsite Support
SIMCO supported the customer’s need for regular onsite service, helping reduce disruption for equipment that was difficult to move, inline with production, or essential to daily operations.By bringing calibration support onsite on a recurring schedule, SIMCO helped the customer reduce equipment movement, improve planning, and keep critical production assets available when teams needed them. - Improve Documentation Confidence Through CERDAAC
Because lost calibration certificates had created quality concerns, SIMCO supported the customer with CERDAAC, its calibration and asset management platform. CERDAAC gives teams centralized access to calibration records, asset history, certificates, due dates, and service status, helping reduce the risk of misplaced documentation or fragmented recordkeeping.For the customer, this meant calibration documentation could be accessed more reliably by quality, operations, and metrology teams when needed. Instead of relying on manual follow-up or supplier-dependent searches, the team gained a clearer system of record for calibration activity. This helped strengthen confidence in certificate availability, audit readiness, and overall calibration control. - Support Supplier Consolidation
SIMCO provided a broader service model that supported calibration and repair needs while creating a foundation for future supplier consolidation. By consolidating more calibration activity with a single accountable partner, the customer could reduce handoffs, improve consistency, and simplify vendor management as the organization continued to grow.
Results:
By selecting SIMCO, the customer established a more reliable calibration support model for a growing cardiovascular medical device manufacturing operation.
The engagement helped the customer:
- Improve confidence in calibration certificate availability
- Reduce operational risk from lost or missing documentation
- Support monthly onsite calibration needs
- Improve turnaround expectations for equipment requiring offsite service
- Create a more accountable service experience for operations and quality teams
- Begin consolidating calibration support with a partner capable of scaling over time
- Strengthen visibility into calibration status, records, and asset history through CERDAAC
“We needed a calibration partner that could support our growth, provide monthly onsite service, and help us regain confidence in our calibration documentation.”
Why It Matters:
For cardiovascular medical device manufacturers, calibration is closely tied to production continuity, quality system control, and audit readiness. When certificates are missing, turnaround times slip, or suppliers are difficult to manage, the impact can extend beyond the metrology team.
A reliable calibration partner helps reduce that risk by keeping critical equipment calibrated, documented, and available for use. With the added visibility of CERDAAC, teams can manage calibration records and asset status with greater confidence.
With SIMCO, the customer gained a stronger foundation for calibration control, supplier consolidation, and scalable support as the organization continues to grow.
Need a calibration partner that can support production-critical equipment, onsite service, and stronger documentation control?
SIMCO helps life sciences and manufacturing organizations keep equipment calibrated, documented, and ready for the work that matters most.
Visit www.SIMCO.com to request a consultation today.