Quality is not created only at the end of production – it must be objectively demonstrated. In the medical device industry, precise measurements, validated inspection processes and documented quality evidence form the basis for safe products, stable manufacturing processes and regulatory compliance. At the same time, manufacturers expect reproducible measurement results, complete traceability and reliable quality data throughout the entire product life cycle.
Gsell supports medical device companies with comprehensive Quality Assurance services – from incoming inspection and First Article Inspection Reports (EMPB/FAI) to CMM measurements, Measurement System Analysis (MSA) and statistical process monitoring (Cpk). Modern metrology, calibrated inspection equipment and standardized inspection processes ensure reliable measurement results and build confidence in the quality of your products and manufacturing processes.
What Does Quality Assurance Mean in the Medical Device Industry?
Quality Assurance encompasses all inspection and measurement processes used to objectively demonstrate the conformity of a medical device. The objective is to reproducibly verify product characteristics, statistically validate manufacturing processes and document quality data in a traceable manner. In addition to conventional component measurement, this includes First Article Inspections (EMPB/FAI), coordinate metrology (CMM), Measurement System Analysis (MSA), Gage R&R studies and process capability analyses (Cpk).
By using modern tactile and optical coordinate measuring machines, temperature-controlled metrology rooms and more than 1,500 calibrated measuring instruments, Gsell ensures that measurement results are reproducible and internationally comparable regardless of the inspection equipment or operator. This provides you with reliable quality evidence for your internal quality processes as well as for customer, audit and regulatory requirements.
Inspection Capabilities – Precision Metrology for Reproducible Quality Evidence
Coordinate Metrology (CMM) – Precise 3D Measurements for Complex Medical Devices
Coordinate metrology using coordinate measuring machines (CMM) enables high-precision measurement of complex components and assemblies. Depending on geometry, material and inspection characteristic, tactile or optical measurement methods are used. Automated measurement programs ensure reproducible results and are particularly suitable for production inspection and demanding quality documentation.
First Article Inspection (EMPB / FAI) – Evidence of Production-Ready Manufacturing
Before series production begins, it must be demonstrated that all specified product characteristics can be reliably manufactured. With First Article Inspection Reports (EMPB) or First Article Inspections (FAI), we document all inspection characteristics in a traceable manner and establish the basis for approvals, validations and stable series production.
Measurement System Analysis (MSA) & Gage R&R – Confidence in Your Measurement Data
Only a suitable measurement system provides reliable quality data. Using Measurement System Analysis (MSA) and Gage R&R studies, we assess the repeatability, reproducibility and suitability of measuring equipment and inspection strategies. This ensures that measurement deviations are not caused by the measurement system itself.
Process Capability Analyses (Cp/Cpk) – Statistically Validate Manufacturing Processes
Process capability analyses show whether a manufacturing process consistently operates within the required tolerances. Statistical evaluation of Cp and Cpk values enables process variation to be identified at an early stage and manufacturing processes to be systematically monitored and continuously improved.
Metrology & Inspection Equipment Expertise
The quality of a measurement result does not depend solely on the accuracy of a measuring instrument. The appropriate metrology, a suitable inspection method and a validated measurement system are critical. Different measurement methods are used depending on component geometry, tolerance and quality requirements. This results in reproducible measurement results, reliable quality evidence and cost-effective inspection processes.
Manual Metrology – Flexible and Cost-Effective for Standard Inspections
Not every inspection characteristic requires an automated coordinate measuring machine. For simple geometries, sampling, incoming inspections or production inspections, manual measuring instruments are often the most cost-effective solution. These include calipers, micrometers, height gages, plug gages and limit gages. They enable rapid inspections while maintaining high accuracy.
Tactile CMM Measurement – Maximum Precision for High-Accuracy Components
Tactile coordinate measurement is particularly suitable for tight tolerances, geometric characteristics and high-precision plastic, metal and composite components. A probe contacts defined measurement points and determines their exact position in three-dimensional space. The method provides the highest measurement accuracy and is used particularly for First Article Inspections, production approvals and complex geometries.
Optical Coordinate Metrology – Non-Contact Measurement for Delicate Structures
Sensitive or very small components can often be measured more economically and gently using optical methods. Camera systems or optical sensors capture contours, radii and freeform surfaces without contact and within a short period of time. Optical metrology offers significant advantages over tactile methods, particularly for thin-walled plastic parts, elastic components or complex contours.
Measurement System Analysis (MSA) & Gage R&R – Is Your Measurement System Suitable?
A measurement result is meaningful only if the measurement system itself operates reliably. Measurement System Analysis (MSA) evaluates whether measuring equipment, measurement methods and operators deliver reproducible results and forms the basis for reliable quality decisions. In international environments, Gage R&R analysis is commonly used for this purpose.
The result is a validated measurement system that delivers reliable and reproducible measurement results and serves as the basis for approvals, audits and series production.
Process Capability Analysis (Cp/Cpk) – Statistically Validate Manufacturing Processes
A single measurement only shows the condition of an individual component. Process capability analyses, by contrast, evaluate how consistently a manufacturing process operates within the specified tolerances over an extended period.
The Cp value describes the theoretical potential of a process, while the Cpk value additionally considers how well the process is centered within the tolerance limits. Both metrics provide an objective assessment of long-term process capability.
The results are used to
- demonstrate the series-production capability of a manufacturing process,
- identify process variation at an early stage,
- initiate corrective actions in a targeted manner,
- reduce scrap and rework,
- and objectively document customer and regulatory requirements.
This results in a statistically validated manufacturing process with a high level of process reliability and reproducible product quality.
Calibrated Inspection Equipment & Temperature-Controlled Metrology Rooms
Even the smallest temperature fluctuations can affect high-precision measurement results. For this reason, demanding measurements are performed in temperature-controlled metrology rooms using regularly calibrated inspection equipment. More than 1,500 calibrated measuring instruments and defined calibration intervals ensure reproducible and internationally comparable measurement results.
Independent Second-Person Verification – Additional Assurance for Critical Inspection Characteristics
For safety-critical or function-critical inspections, independent second-person verification can be used. Measurement results are independently reviewed or approved by a second qualified person. This additional control increases process reliability and reduces the risk of incorrect assessments for particularly demanding medical devices.
Inspection Fixtures & Fit Checks – Efficient Verification of Function and Precision
Not all quality characteristics can be economically inspected using a coordinate measuring machine. For function-critical assemblies, we develop and use customer-specific inspection and fit-check fixtures that allow components to be positioned and inspected under defined conditions. Precision pins, gages or reference elements enable fast and reproducible verification of fits, targeting holes or interfaces. Particularly for surgical targeting devices, instruments or assemblies, this enables function and dimensional accuracy to be efficiently ensured during volume production.
Functional Testing – Verifying Quality Under Actual Use Conditions
Dimensional accuracy alone does not guarantee a functional medical device. We therefore supplement geometric measurements with product-specific functional testing. Depending on the application, this may include testing release mechanisms, clamping forces, motion sequences, spring forces or targeting systems. Testing is performed according to defined inspection instructions and documented procedures, ensuring that not only individual dimensions but also the actual function of the finished medical device is reliably demonstrated.
YOUR GSELL-PLUS – Why Medical Device Companies Choose Gsell for Quality Assurance
Reliable quality data builds confidence – in products, manufacturing processes and suppliers. Gsell combines modern metrology with many years of experience in the medical device industry and supports you with objective quality evidence throughout the entire product life cycle.
+ Full-Service Partner for Quality Assurance
From incoming inspection, CMM measurements, First Article Inspection Reports (EMPB/FAI), Measurement System Analysis (MSA) and process capability analyses (Cp/Cpk) to functional testing, you receive the complete range of Quality Assurance services from a single partner. This reduces interfaces and simplifies collaboration.
+ Broad Range of Measurement and Inspection Technologies
Manual metrology, tactile and optical coordinate metrology, automated measurement programs, inspection fixtures and functional testing enable the most cost-effective inspection strategy for a wide range of components and assemblies.
+ Engineering Expertise for Reliable Quality Evidence
Quality inspection involves more than measurement alone. We support you with First Article Inspections, Measurement System Analysis, process capability studies and the evaluation of complex quality characteristics. This provides reliable quality data as the basis for approvals, audits and regulatory requirements.
+ Process Reliability Through Standardized Inspection Procedures
Calibrated measuring equipment, temperature-controlled metrology rooms, documented inspection processes and validated measurement systems ensure reproducible measurement results and consistently high inspection quality.
+ Family-Owned – Flexible, Personal and Long-Term
As an independent Swiss family-owned company, we stand for short decision-making paths, dedicated trusted points of contact and long-term partnerships. This enables us to respond flexibly to new requirements and tailor our services to your project.
+ Quality You Can Rely On
Precision metrology, objective quality evidence and consistent documentation build confidence throughout the entire supply chain. This enables us to support you in reliably transitioning development projects into volume production and consistently meeting the highest quality requirements in the medical device industry.
FAQ – Frequently Asked Questions About Quality Assurance in the Medical Device Industry
Can Measurement Reports Be Adapted to Our Internal Quality Requirements?
Yes. Inspection reports, EMPB/FAI, measurement reports and statistical evaluations can be tailored to customer-specific requirements, drawings and approval processes. This allows measurement results to be integrated directly into existing quality and supplier processes.
How Do You Ensure That Measurement Results Are Comparable Between Customer and Supplier?
Measurement correlation can be performed for critical characteristics. The measurement method, datum system, fixturing and measuring equipment used by the customer and Gsell are compared to identify deviations at an early stage and ensure consistent interpretation of measurement results.
When Is an MSA or Gage R&R Appropriate?
Measurement System Analysis is appropriate when it is necessary to ensure that an inspection process is sufficiently repeatable and reproducible. Particularly for tight tolerances, new measurement methods, production approvals or customer-specific quality requirements, it helps objectively assess the influence of measuring equipment and operators.
What Does a Cpk Value Indicate About a Manufacturing Process?
The Cpk value indicates how reliably a process operates within the specified tolerance limits and whether the process is sufficiently centered. Low values indicate increased process variation or unfavorable process centering, providing a concrete basis for process corrections and improvement actions.
When Is CMM Measurement Appropriate and When Is Manual Metrology Sufficient?
CMM measurements are particularly suitable for complex geometries, geometric tolerances and high-precision or automated production inspections. For simple dimensions, rapid sampling or robust inspection characteristics, calibrated manual measuring instruments are often the more efficient solution.
Can Medical Device Functions Be Tested in Addition to Dimensions?
Yes. In addition to geometric inspections, we perform product-specific functional testing. This includes, for example, fit checks, targeting-hole inspections using gage pins, release mechanisms, spring forces or other function-critical characteristics of the finished medical device.
Together, We Ensure the Quality of Your Medical Device
Whether First Article Inspection, CMM measurement, Measurement System Analysis (MSA), process capability analysis (Cp/Cpk) or complex functional testing – we support you in objectively demonstrating your quality requirements and establishing stable volume production processes. Together, we create reliable quality data as the basis for clinically safe medical devices and successful audits.
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