When people in MedTech talk about quality and compliance, the focus is usually on product design, design controls, and regulatory submissions. Those are important, but there is another critical piece that often does not get the same attention: equipment management.
Every physical medical device, whether in early development or full commercial production, depends on equipment to be built, tested, and eventually scaled. Managing that equipment in a structured and compliant way is just as essential as managing the product design.
This blog explores why equipment management matters, what it involves, how it is connected to product development, and how QuickVault by Veeva brings it together in a modern eQMS.
Why Equipment Management is Important
Regulatory authorities, like the FDA, expect medical device companies to demonstrate that the equipment they use is qualified, calibrated, and maintained (see 21 CFR 820.70). These regulations exist because if equipment is out of calibration, not properly maintained or qualified/validated, the products of which it produces cannot be trusted to perform to specification.
These examples demonstrate the importance of proper equipment management in MedTech:
- If a plastic injection molding machine used for device housings is not qualified, the dimensions of the parts might be inconsistent.
- If a test rig used for tensile testing is out of calibration, the strength data generated could be misleading, resulting in product field failures.
- If preventative maintenance is skipped on critical production tools, equipment failure could compromise device quality or delay manufacturing timelines.
In all these cases, regulators will expect companies to show documented evidence that equipment is properly managed. Without it, design verification and validation data may not be accepted, and commercial production could be delayed.
What Equipment Management Entails
Equipment management is more than just keeping a spreadsheet of the pieces of equipment used in R&D, Incoming Quality Control (IQC), manufacturing etc. It typically includes:
- Equipment Qualification: Demonstrating that the equipment operates as intended.
- Validation: Showing that the equipment can consistently produce results that meet requirements. This may include Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), etc.
- Calibration: Ensuring that instruments and tools remain accurate over time.
- Preventative Maintenance (PM): Keeping machines in working condition to avoid breakdowns and ensure ongoing compliance (similar to recurring oil changes for a car).
- Corrective Maintenance (CM): Conducting equipment repair, following the discovery of it being out of specification, or following a breakdown. This shall trigger a non-conformance report to assess product impact.
- Change Control: Managing updates, repairs, or modifications to ensure equipment remains validated.
- Lockout/Tag out (LOTO): The process of temporarily taking a piece of equipment out of service, usually as part of an issue such as a non-conformance, equipment breakdown, etc.
These activities all need to be documented, reviewed, and linked to the products or processes they affect. In practice, that often means a lot of manual tracking, and can in many times require a full-time position.
How Equipment is Typically Managed in MedTech Today
For many MedTech companies, especially smaller or pre-commercial ones, equipment management is still handled through spreadsheets, shared drives, Outlook/Google calendar, and paper binders. This approach works for a while, but quickly creates challenges:
- Records get lost or go out of date.
- Scheduled calibration and maintenance is missed.
- Missing or unclear link between equipment and the products built on it.
- Audits become stressful because evidence is scattered across different files and disconnected tools.
- Scaling operations exposes gaps that were hidden when only a handful of devices were being made.
This patchwork approach often holds companies back at critical moments, such as during FDA inspections, ISO audits, or investor due diligence.
The Overlooked Role of Equipment Management in the Pre-Commercial Stage
One area where equipment management is especially important, but rarely discussed, is the pre-commercial stage when medical devices are being developed and tested. When most people think of design controls, they focus on the design of the device itself.
What often gets missed is that physical prototypes and test units need to be built under controlled conditions for design verification and validation (DV&V) testing.
Regulatory authorities demand that there is clear documentation of how devices used for DV&V testing were built: what materials were used, who built the devices, what equipment was used, and how that equipment qualified and controlled. Below are a few top areas to consider:
- Design Verification Builds: At this stage, every dimension and tolerance is being checked. If the equipment producing those parts is not calibrated or qualified, then the verification data is not credible.
- Design Validation Testing: Validation requires medical devices to be built under conditions that are close to production. Regulators want to see that the devices being used in DV&V reflect what patients will eventually receive. That means the equipment used to build them must be qualified and controlled.
- Bridging R&D and Manufacturing: This is where many MedTech startups stumble. They focus on design inputs and risk management, but not on whether the equipment used for test builds is managed. If regulators question the chain of evidence, companies may have to repeat expensive testing.
By integrating equipment management early, companies can build prototypes and test units with confidence. QuickVault by Veeva makes this possible with its eQMS solution that lets you link equipment records directly to the builds and tests they support.
How QuickVault Helps MedTech Teams Manage Your Equipment
QuickVault includes equipment management as a core part of its modern eQMS. Instead of tracking calibration and maintenance in spreadsheets or separate systems, companies can manage everything in one place.
Within the QuickVault platform, MedTech teams can:
- Track equipment qualification, calibration, and maintenance in a structured way.
- Get email notifications about upcoming equipment tasks, such as calibration and maintenance.
- Link equipment records (validation protocols, reports, etc.) directly to product builds, tests, and quality events.
- Automatically flag equipment that is overdue for calibration or maintenance.
- Generate audit-ready reports in minutes rather than sifting through files.
When equipment management is built into the same system as quality processes, companies can show regulators, auditors, and partners that their operations are under control from the very beginning. The result is not just compliance, but confidence.
The Bigger Picture
MedTech companies cannot afford to treat equipment as an afterthought. Whether in the pre-commercial stage, where verification and validation data are being generated, or in full commercial manufacturing, equipment management is foundational.
Without it, the credibility of device performance data is at risk. With it, companies can accelerate their path to market and scale with fewer surprises.
QuickVault by Veeva makes this possible by giving MedTech innovators a single, modern platform to manage design, quality, and equipment together. It is time to expand the conversation in MedTech beyond just design controls. The equipment that builds and tests those designs matters just as much.
