Testing and Process Technology for Medical Devices:
Precision for Patient Safety
Maximum reliability for irreplaceable security
Medical technology is a field in which precision is a matter of life and health. The demands placed on testing and process technology in this field are extremely high: the highest level of reliability, complete traceability, and compliance with the strictest regulatory requirements are essential. Errors are unacceptable and can have fatal consequences.
What Matters in Medical Technology
Absolute Reliability
Every component must function flawlessly, without compromise.
Biocompatibility & Sterility
Materials and processes must meet medical standards.
Complete Traceability
Every step must be documented and traceable.
Regulatory Compliance
Compliance with standards such as ISO 13485 and FDA requirements.
Systems Tailored to Medical Technology Requirements
Our testing and process systems are designed to operate reliably and precisely and to integrate seamlessly into your quality-critical manufacturing processes. Cycle time, test sequences, and process behavior are specifically coordinated to ensure the highest levels of safety and compliance.
- Designed to meet the highest quality and safety standards
- Integration into existing production lines under cleanroom conditions
- Consistent and repeatable processes for critical components
Minimization of risks through precise and documented results
Testing and Process Solutions for Medical Standards
Medical components are tested under conditions that reflect their intended use and comply with strict regulatory requirements. Dimensional tolerances, pressure profiles, and leak rates—even in extreme conditions—are specifically defined to ensure meaningful results that guarantee patient safety.
- Defined pressure build-up and release profiles for medical applications
- Simulation of dynamic loads and physiological conditions
- Testing in relevant pressure ranges and at minimal leak rates
- Functional testing, including endurance testing
- Dimensional accuracy testing
- Reproducible test conditions under validated processes
Typical Tasks in Medical Technology
Pacemakers
Leak tests to ensure housing integrity and protect the electronics
Needles
Functional and flow tests
Syringes
Leak and functional tests to ensure proper functionality
Pumps
Functional and leak tests to ensure reliable fluid delivery and prevent leaks.
Vials (injection vials)
Leak tests to prevent contamination and maintain the sterility of the contents.
This is how we’ve solved it for others
Find out how companies are using aprotec’s solutions to meet a wide range of industry requirements and make targeted improvements to their processes. The case studies demonstrate how efficiency can be boosted and specific challenges successfully overcome – let them inspire you in your own projects.
Test- and Inspection System
- Test- and Inspection System
- • Automotive
Helium Leak Testing System
Test- and Inspection System
- Test- and Inspection System
- • Subsea
Deep-Sea Simulator
Test- and Inspection System
- Test- and Inspection System
- • Semiconductor
WaferVision HSM-200
Test- and Inspection System
- Test- and Inspection System
- • Automotive
Helium Leak Testing System
- 8 s helium leak detection cycle time per component
- 10⁻⁶ mbar·l/s detectable leak rate (helium)
- 5 bar test pressure with 10% helium
Zone Melting System
Why Aprotec?
Direct contact
You speak directly with the people in charge, not through multiple layers of management
Integrated solutions instead of standalone solutions
Pressure, leak, functional, and measurement tests can be combined in a single system
Experience with a wide range of testing tasks
From simple production line testing to fully automated special applications
Designed for extreme conditions
High pressures, minute leaks, or precise measurement requirements are specifically accommodated
Scalable from single tests to series production
From manual test stations to fully automated systems with cyclic operation
Get Expert Advice
Do you have questions or are you unsure which system is the right fit for your requirements? No problem. We are happy to advise you personally and work with you to find the ideal solution for your application. Benefit from our years of experience, an honest assessment, and professional guidance — tailored to your needs and with no obligation.
Contact person
Michael Landgraf
Managing Director
- m.landgraf@aprotec-gmbh.de
- +49 9353 982460-11