Quality Standards

Quality is Our Number One Priority

Millions of patients and caregivers use our products for prevention and treatment globally. At Wellell, patients and caregivers have always been our top priorities. They are the reasons we work tirelessly in improving every stage of our product development process, including designing, testing, and manufacturing.

Wellell's Quality-First Principle

Wellell's professional obligation is to provide clinically validated, humanizing, and comfortable support to improve clinical outcomes and digital well-being for patients, caregivers, and healthcare providers. Wellell has been successful in fulfiling and sustaining such a big responsibility because of our core value, 'Do It Right The First Time.'

Certifications & Accreditations

Obtaining more than 190 world-class safety certifications, including ISO 13485, and 337 medical product accreditations such as US FDA 510(K), MDD, 93/42/EEC, NMPA, Australia TGA, Health Canada, and TFDA recognitions, show our dedication in designing and developing reliable, quality medical products.

The Top Standard is Wellell's Standard

Every Wellell product passes IES 60068-2 complied reliability and functional-oriented testing such as operating temperature, pressure, noise, fabric endurability, and compression life test. Thus, patients, caregivers, and partners can entrust Wellell to deliver world-class quality products, experiences, and performances.

Awards & Recognitions
2022 November

Optima Prone, Taiwan Excellence Gold Award 2022

2021 November

WiZARD 510 CPAP Mask, Taiwan Excellence Gold Award 2021

2020 November

Pro-care Turn Lateral Turning Mattress, 28th Taiwan Excellence Award

2020 July

Pro-care Turn Lateral Turning Mattress, Taipei Biotech Award

2019 November

Pro-care Optima Air Mattress & Wizard 310/320 CPAP Mask, 27th Taiwan Excellence Award

2018 November

Flex-Air Hybrid Mattress, 26th Taiwan Excellence Award

2016 July

XT series CPAP System& WiZARD series CPAP Mask, Taipei Biotech Award

2015 November

Pro-care series Air Mattress, 23th Taiwan Excellence Award

2014 November

NPWT Care System, 22th Taiwan Excellence Sliver Award

2014 November

Serene Low Air Loss, 22th Taiwan Excellence Award

2014 November

WiZARD 230 CPAP Mask, 22th Taiwan Excellence Award

2014 November

Domus Auto Air Mattress, 22th Taiwan Excellence Award

2014 July

iCH Auto CPAP System, Taipei Biotech Award

2013 December

NPWT Care System, Sliver Award of the Drug Research and Development Science and Technology from the Department of Health, Industrial Innovation Achievement Award

2012 December

WiZARD series CPAP Mask, Silver Award of the Drug Research and Development Science and Technology from the Department of Health

2012 November

iCH Auto CPAP System, 20th Taiwan Excellence Silver Award