Medical Device Heater Factory

Frequently Asked Questions

• Q: Are your heaters certified for medical use?

• A: We manufacture our heaters under an ISO 13485 quality management system. While the heater is a component, we can provide material certifications and support for your end-product certification process.

• Q: What does USP Class VI certified silicone mean?

• A: USP Class VI is a biocompatibility standard from the United States Pharmacopeia. It means the silicone has been tested and proven safe for use in applications with prolonged skin contact or short-term mucosal contact.

• Q: Can you design a heater for a disposable medical device?

• A: Yes, we specialize in designing cost-effective heaters, such as etched foil or thin polyimide heaters, that are suitable for single-use disposable devices.

• Q: Can you integrate sensors into your medical heaters?

• A: Absolutely. We can integrate thermistors, RTDs, or thermocouples directly into the heater assembly to provide highly accurate and responsive temperature feedback.

• Q: What is the typical lead time for a custom medical heater?

• A: Lead times vary based on complexity and material availability. For new custom designs, it's typically 4-6 weeks to allow for design validation and material procurement.

• Q: How do you ensure the safety of your patient warming heaters?

• A: We incorporate multiple safety features, including redundant temperature sensors, fuses, and strict control over maximum surface temperatures, in accordance with IEC 60601-1 standards.

• Q: Can you provide heaters with RoHS and REACH compliance?

• A: Yes, all our components can be sourced to be fully compliant with RoHS and REACH regulations, which is essential for medical devices sold in Europe and other regions.

• Q: Do you offer design support for new medical device concepts?

• A: Yes, we are more than a supplier; we are a thermal solutions partner. Our engineering team can work with you from the concept stage to design the optimal heating solution for your device.