Lifa Air Plc has been awarded ISO 13485 certificate for medical device quality management

Lifa Air Oyj's quality management system is certified in accordance with the requirements of the ISO 13485:2016 standard for medical devices. The certification shows that the organization is able to offer medical devices and related services that regularly meet the requirements of customers and authorities.

The company's management system was certified for the first time more than 20 years ago with the ISO 14001 environmental system. Three years later, a quality management system meeting the requirements of the ISO 9001 standard was certified. The now certified ISO 13485 quality management system is built to complement the ISO 9001 quality management system to ensure that health care requirements are met for the manufacture and sale of surgical mouth-nose masks.

ISO 13485 certification is part of the company's long-term strategy. "Our company has started international operations to increase the sales of Lifa Air's surgical mouth-nose masks outside the borders of Finland. In accordance with the requirements, our company and our products are registered in the European medical device database EUDAMED. In addition to registration in that register, professional customers require an ISO 13485 quality certificate. We see this as strengthening our company's potential. to grow our business internationally in the field of medical devices", commented Vesa Mäkipää, CEO of Lifa Air Oyj.

Lifa Air Oyj's quality and environment manager Mirella Lehtiö adds, "Quality management according to the ISO 13485 standard ensures that the industry's strict requirements are met and offers effective tools for developing operations. The ISO 13485 certification is proof of Lifa Air's commitment to high quality and continuous development."

The ISO 13485:2016 certificate was granted to Lifa Air by the certification company LRQA on June 20, 2022. The scope of the certification is the manufacture and sale of surgical mouth-nose protection.

More information:

Vesa Mäkipää
Managing director
+358 50 63 696

About Lifa Air

Lifa Air is a Finnish technology company founded in 1988 offering solutions for clean breathing air, whose head office is located in Helsinki. Lifa Air's business is divided into three business areas, which are air purifiers, respirators and surgical mouth-nose masks, as well as ventilation hygiene products.

Lifa Air is a pioneer in the development of various products that enable cleaner and healthier breathing air. The company's competitive advantages are based on the company's own technology and efficient procurement and production. The company's clean breathing air solutions can be used in many different spaces, such as homes, schools, offices and factories. In addition, Lifa Air's products are suitable for many different needs, from private use to professional use.

Lifa Air has more than 30 years of experience serving a global customer network, and the Company's products have been sold to more than a hundred countries. Lifa Air has a diverse customer base, which includes companies from several different industries, such as healthcare, transport, tourism, hotel, construction and real estate as well as the pharmaceutical and food industries, public administration operators and consumer customers through direct sales and trade.

In 2021, Lifa Air Group's turnover was EUR 17.8 million (2020: EUR 10.8 million) and the Company's EBITDA was EUR 5.9 million (2020: EUR 2.9 million). The company had a total of 58 employees on 31 December 2021.

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