# Health care

The challenge of the market

The outbreak of the COVID-19 pandemic has significantly expanded the role of portable medical devices in the medical industry. With the growing emphasis on health management, portable medical devices have experienced increased demand in the home setting, which has directly translated into increased demand for batteries for such devices. In line with current standards, incl. ANSI/AAMI ES 60601-1, medical devices and batteries must comply with the risk management model, a basic performance concept that helps measure the impact of a device on user and patient safety. A suitably defined certification is therefore essential from the battery design stage.

How do we deal with this?

 Safety is always paramount in battery design, but it must be enhanced for the healthcare market. This is something we fully understand and work diligently to achieve. If your required safety level can’t be matched using NMC/NCA lithium-ion technology, we also have experience in Ni-MH and other cell chemistry, ensuring a wide range of solutions for our customers.

Certification requirements are also exceptionally important in healthcare, and the requirements for certification are generally far stricter than with other devices, such as home appliances. We have a dedicated team to create complex DVP&R (Design Validation Plan & Report), to ensure compliance with all certification requirements.

What’s more, we always document every change made to the product and production process, to ensure product safety and compatibility are not adversely impacted.

 
 
 
 What standard is essential for medical device batteries to comply with?
 
 Medical device batteries must comply with the risk management model and basic performance concept outlined in standards such as ANSI/AAMI ES 60601-1, which measures the impact of the device on user and patient safety.
 
 
 
 
 
 Why has the demand for portable medical device batteries increased?
 
 The demand has increased due to the expanded role of portable medical devices following the COVID-19 pandemic and the growing emphasis on health management in the home setting.
 
 
 
 
 
 What is a DVP&R and why is it important for medical batteries?
 
 A DVP&R (Design Validation Plan & Report) is a complex document created by a dedicated team to rigorously test and validate the battery design, ensuring full compliance with all stringent certification requirements for the healthcare market.
 
 
 
 

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