GuidedSMILE™ Earns ISO 13485:2016 Certification for Medical Device Quality Management

INDEPENDENCE, Ohio, Oct. 6, 2026 /PRNewswire/ -- GuidedSMILE™ has earned ISO 13485:2016 certification, an internationally recognized quality management standard specifically designed for organizations involved in the design, production, installation, and servicing of medical devices.

The certification covers GuidedSMILE's production of Class I (NDP) surgical guides and follows an independent assessment of the company's quality management system by Amtivo (USA) Inc.

Quality management is far from new to GuidedSMILE. The company has strictly followed FDA regulations and guidance since its inception. As guided surgery has grown, the systems behind the technology matter more than ever. Quality controls and safeguards play a critical role in moving a digital plan from the screen to the operatory. ISO certification now formalizes that commitment, validating GuidedSMILE's dedication to process excellence, uncompromising documentation, risk management, and regulatory compliance.

"Guided surgery depends on a lot more than planning and a good design," said Alan Banks, President of GuidedSMILE. "Doctors and labs need to know there is a disciplined process behind every case. ISO certification gives us an independently assessed quality framework with strict requirements for production, safety, design, and regulatory compliance as GuidedSMILE grows. ISO certification also sets GuidedSMILE apart in a segment where this level of independently assessed quality management is unusual."

ISO 13485 establishes quality management system requirements specific to the medical device industry. The standard addresses areas including process control, documentation, risk management, product realization, performance evaluation, and regulatory requirements.

For clinicians and laboratory partners, the certification provides additional assurance that the surgical guides they rely on are produced within a documented and independently assessed quality management system. It also provides GuidedSMILE with a stronger foundation for continued product development, collaboration, and growth.

GuidedSMILE's ISO 13485:2016 certification was issued September 24, 2026, and is part of a three-year certification cycle subject to annual assessments.

About GuidedSMILE™

GuidedSMILE LLC, based in Independence, Ohio, develops patented and standard guided surgery products and digital workflows for dental implant treatment. Its portfolio includes CHROME GuidedSMILE® and a family of guided solutions designed to support clinicians and laboratories through diagnosis, planning, surgery, provisionalization, and restoration. GuidedSMILE's expertise supports the dental team with structure, efficiency, and predictability.

SOURCE GuidedSMILE