RESOURCES
Medical Power Supplies with Superior Quality and Reliability
Astrodyne TDI is certified to ISO 13485, and all our medical power supplies are designed and developed with the patient in mind. The Astrodyne TDI team works closely with customers and partners to understand how the power solutions will be utilized and their environment. This is a critical step in the design process of both power supplies and EMI filters because it could lead to challenges with reliability if the power supply manufacturer is not knowledgeable about the application. During the design phase of the power supply, Astrodyne TDI ensures that all failure modes are determined using Design FMEAs.
The need for repeatability and reliability is crucial with medical power supplies or power solutions specific to the healthcare environment. Once the power supply is designed, Astrodyne TDI’s Process Engineers work with the Quality and Engineering teams to generate control plans and process FMEAs. To provide the best quality and reliability, Astrodyne TDI validates all new equipment and processes. Any new manufacturing equipment goes through Installation Qualifications, while the manufacturing processes must complete Operational Qualifications and Performance Qualifications. Test Method Validations are also utilized to ensure inspections and identify potential product anomalies.
Astrodyne TDI has a very robust training curriculum for manufacturing employees. We are constantly emphasizing 21 CFR Part 820 and creating awareness about the product end-user. We believe this ties Astrodyne TDI employees to the manufactured products, giving them pride in the power supplies they assemble. Astrodyne TDI also ensures that the power supply manufacturing team is trained to inspect solder joints to IPC 610, as well as trained to the J standard. Our medical power supplies are also individually serialized which helps with manufacturing traceability. Batch records or device history records are kept for every manufacturing lot with traceability to each serialized power supply.
Change control is a huge topic for medical device manufacturers. Astrodyne TDI understands that changes must be evaluated and often submitted to the FDA or other regulatory agencies. Based on customer requirements, we have varying levels of configuration management. At its most stringent, we can set products to what we call Configuration Control Level A, which means that we cannot make any changes to materials or processes without prior customer approval.
These are some of the processes that Astrodyne TDI has implemented to ensure that every power supply is manufactured to the highest quality and reliability standards. For more information regarding Astrodyne TDI medical power supplies and power solutions, please contact our team.