Services for medical device manufacturers

Our services for medical device manufacturers as well as plant and machinery manufacturers operating in environments where medtech equipment and pharmaceutical goods are produced: We support you in developing, selecting, integrating and maintaining the right process monitoring systems for production, assembly and product testing.

• Our sensor positioning service assists you with correct sensor installation, helping you to determine meaningful quality gates
• Application training for sensors and process monitoring systems
• Process investigations and tests on site at customer's premises or on our own test systems
• Support with installing sensors and commissioning (IQ) including connection to third-party systems, e.g. via fieldbus or OPC UA
• Support with mold validation to determine process limits (OQ)
• Compliance with QM system requirements
• Reducing the risk of incorrect use -> reliable and stable processes
• Advice on data analysis and data models
• Calibration of sensors and measuring chains directly on the plant, or at the Kistler calibration laboratory with traceability to ISO 17025 (depending on the application case)

Many customers need support to clarify questions and take decisions on calibrating and managing their process monitoring equipment:

• Why is calibration necessary?
• How often should equipment be calibrated / how are the intervals defined?
• Should we calibrate individual sensors or measuring chains?
• Traceable calibrations or service calibrations?

Kistler will be glad to advise you, and we will assist you with setting up a management system for your test and measurement equipment to make sure that you are audit-proof. 

• In-situ calibrations – special services for medical device manufacturers as well as plant and machinery manufacturers
• To meet customers' special requirements and in cases where the measurement setup cannot be dismantled (as happens in medtech applications), we will perform in-situ calibrations at your premises.
• An in-situ calibration may also be required for regulatory reasons, or because of the need to minimize downtimes caused by time-consuming disassembly procedures.