Medical Power Supply Quality and Reliability
Автор: Astrodyne TDI
Загружено: 2021-10-12
Просмотров: 339
Astrodyne TDI is certified to ISO 13485, and all our medical power supplies are designed and developed with the patient in mind. During the design phase of power supplies, Astrodyne TDI ensures that all failure modes are determined using Design FMEAs. The need for repeatability and reliability is also crucial with medical power supplies or power solutions specific to the healthcare environment. 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. Additionally, 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.
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