Case Study

How IAF is helping small companies improve oral health worldwide

More than 90% of companies making dental equipment are small businesses. And although oral healthcare is considered non-life threatening, dental caries (tooth decay) is the most common childhood disease, 7 times more common than asthma.

Our company Aseptico provides very specialized ‘Portable Dental Units’ that allow dentists to treat patients anywhere in the world, whether in the jungles of Thailand, where doctors carry our equipment with help from elephants, or by special care dentists, working within a nursing home among the most developed nations of the world. We support oral healthcare, anywhere!

Established in 1975, Aseptico Inc. is a small and family-owned business that has become known worldwide for the quality of and capabilities of our Portable Dental Systems. We now sell our products in more than 100 economies.

Our hard-earned ISO 13485 quality management system certificate demonstrates to medical device regulators worldwide, that we design and manufacture our dental products with the focus on patient safety and care, which ISO 13485 requires.

Having an internationally accredited certificate, with an IAF Multilateral Recognition Arrangement (MLA) mark allows us to reach more economies and the most remote places of the world, where dental care is most scarce.

As a small business, we cannot afford to meet 100 different quality system regulations that each economy might impose, so having one internationally accepted ISO 13485 certificate that can be accepted by so many regulators worldwide, and so quickly verified by anyone using the new IAF CertSearch database, paves the way for our products to help more people in more economies than ever before.

As more regulators are willing to award companies like ours, against competitors that try to use counterfeit ISO 13485 certificates, the new IAF CertSearch database isn’t just helping us gain access, it’s also hindering unscrupulous competitors that would dare to use counterfeit certificates and put more patients at more risk.

Summary

Without internationally recognized accreditation and the new IAF CertSearch database, small companies making dental products like ours cannot help the men, women and children that are hurting for oral healthcare worldwide. IAF CertSearch is also closing the door on those that use counterfeit certificates to fool regulators into thinking they have put in the same effort we have, to make better quality dental equipment.

Background

Aseptico Inc. is located in Woodinville, WA USA and has been making dental equipment since 1975. Aseptico is family owned and classified as a ‘small business’ in the United States. Aseptico is also a member of the Dental Trade Alliance, which is comprised of mostly small-sized companies that make dental products of all types. 87% of DTA members meet the criteria as ‘small’ enterprises under the US Small Business Administration Criteria.

Strategy

By achieving certification to ISO 13485:2016 using a certification body that is accredited by an IAF MLA signatory, Aseptico has a certificate that is accepted by more economies that are increasingly using ISO 13485 to regulate medical devices. ISO 13485 is the only internationally recognized quality management system, designed for regulators to accept, to protect the public, while ensuring better medical devices are available for delivering the best patient care.

Results and impact

Through small companies holding an IAF-backed ISO 13485 certificate that can be validated quickly using IAF CertSearch, medical device regulators can be assured they are allowing medical devices into their country that have been designed and manufactured in such a way to ensure patients receiving care are getting safe and effective treatments.

As more medical device regulators are recognizing ISO 13485, smaller companies making novel devices can better afford to sell their products into more economies. By supporting small businesses better, ‘Certified once, accepted everywhere’ means we can provide more and better treatment options to anywhere in the world.

Contact

Name: IAF and ILAC Secretaries
Organisation: Compiled by IAF and ILAC