Machine Vision for Medical Device Manufacturing

In regulated medical device manufacturing, it may not be sufficient simply to classify products as acceptable or defective. Depending on the intended use and the manufacturer’s quality processes, inspection results, system changes, user actions and relevant production data may also need to be documented in a traceable manner.

For manufacturers subject to US medical device requirements, the FDA Quality Management System Regulation under 21 CFR Part 820 is particularly relevant. The QMSR incorporates ISO 13485:2016 by reference as the foundational quality management system standard for medical devices.

When an inspection system creates or manages quality-relevant electronic records or electronic signatures, requirements arising from 21 CFR Part 11 may also apply, depending on the intended use.

For products distributed internationally, additional requirements such as the European Medical Device Regulation, the In Vitro Diagnostic Medical Devices Regulation or other national regulations may also need to be considered.

These requirements apply to the manufacturer and its quality management system. An inspection system alone does not establish FDA or regulatory compliance. However, OCTUM can provide technical functions and documentation that support the manufacturer’s quality, qualification and validation processes.

Possible system functions include:

• Role-based user and access management
• Audit trail
• Controlled recipe and product configuration management
• Version and change history
• Storage of inspection and event data
• Product, lot and work order assignment
• Data integrity and traceability
• Interfaces to PLCs, MES and higher-level systems
• Documentation supporting qualification and validation

The specific system configuration depends on the intended use, product risk, operational processes, quality management system and validation strategy of the manufacturer.

>> Explore system functions for regulated manufacturing

Measurement System Analysis and Repeatable Inspection Results

For geometrical and dimensional inspection tasks, resolution, repeatability, reproducibility, tolerances, part presentation, environmental conditions and reference parts are considered during system design.

Depending on the application, OCTUM can provide project-specific support for measurement system capability studies and repeatability and reproducibility evaluations. The procedure, sample parts and acceptance criteria are defined jointly with the manufacturer.

Reliable automated inspection depends on more than the camera alone. Cameras, optics and lighting must make the relevant quality characteristics consistently visible. The inspection software must evaluate the images within the available cycle time.

At the same time, part handling, triggering, machine communication, pass/fail decisions, reject handling, operator interaction and data flow must be coordinated with one another.

OCTUM integrates machine vision and AOI systems into both new machine designs and existing production lines. Depending on the project, the following aspects are considered:

• Camera, optics and lighting concept
• Part handling and inspection position
• Material and surface properties
• Target throughput and trigger timing
• Connection to the PLC and machine control system
• Interfaces to MES or other higher-level systems
• Pass/fail decisions and reject handling
• Human-machine interface and product configuration management
• Storage and transfer of inspection data
• Long-term maintainability and serviceability

>> Learn more about system integration
>> Evaluate technical feasibility

OCTUM has been developing machine vision and AOI systems for demanding production environments since 1996. Customers across the Americas benefit from regional coordination through OCTUM USA and the technical expertise of OCTUM Germany.

• Experience in industrial machine vision since 1996
• More than 6,000 systems installed worldwide
• OCTUM USA location in Charlotte, North Carolina
• Regional coordination for the United States, Central America and South America
• Service technicians based in the United States
• Direct access to OCTUM’s application, software and engineering expertise in Germany
• Modular inspection solutions for medical devices and laboratory consumables
• Proprietary software solutions such as OCVis, OCTUMISEr and CV-Inspect
• Experience with regulated manufacturing environments
• Integration into new machines and existing production lines
• Support from feasibility studies through commissioning, service and training

Would you like to inspect a medical device, laboratory consumable, component or production step automatically?

Tell us about your product, the relevant quality characteristics, known defect types, tolerances, target throughput and planned installation conditions. Please also let us know about any requirements relating to documentation, data connectivity, measurement system analysis or validation.

Together, we will determine which machine vision solution is technically suitable and can be integrated reliably into your manufacturing process.

OCTUM USA coordinates the next steps for customers in the United States, Central America and South America, with additional engineering and application support available from OCTUM Germany.