The medical industry places significant emphasis on quality and patient safety due to the critical impact electric devices have on end users.
Medical device manufacturers prioritize the implementation of automated test and measurement solutions throughout the various stages of the product life cycle. These stages encompass product concept, design, electronic development and construction, manufacturing, and maintenance service, ensuring rigorous quality assurance across the entire process.
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With our years of experience in the medical industry we not only focus on the product test but also can assist in medical device product development and meeting industry safety standards.
During medical device testing it is often required to have a custom test software developed to ensure we can meet the industry standards to obtain critical certifications for the final distribution of the product. KT has a large team of software developers working to meet these requirements.
Medical device test systems are a challenge to design and integrate with software, so once we are successful, we assist our customers to standardize the equipment, process and software to save costs in future deployments.
For a leading medical device manufacturer we assisted in the product development process. Specifically, we were involved in the optical sensor head development that included:
- Software and Vision Algorithm Development
- Validation Against ISO13485
- Prototype Manufacturing
For a medical device company, we were involved in all stages of development (Design, Development, Validation & Verification and EMC) for a Dental in Surgery Laser System.
Key Parameter of the Laser System:
- Touch Panel System for Intuitive Operation
- 30 Watt Laser, 635 nm
- CW 0-15kHz Laser Frequency
- Patented Hand Piece with Glass Fiber
- Patient Data Storage
We also assisted the client to obtain Medical Certification for this device.
For a global leading medical device manufacturer we developed a test solution, based on LEON Inline, testing pacemakers in production.
- Temperature test the DUT to 37 degrees
- Test up to 8 DUTs in parallel
- Cover all functional test items according to the specification
- Fully automatic DUT loader & unloader
In an effort to standardize all these test equipment globally the Konrad ABex architecture was implemented and all test software standardized as well.
Let us know what you're working on and how we can help you get there through our long term experience in large high tech projects.
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