Quality and Compliance

Optalmed’s quality management system (QMS) follows both federal and international requirements.

EUDAMED SRN: US-MF-000021394


Quality Policy


Optalmed’s dedication to producing high quality products demonstrates our commitment to meet or exceed customer expectations. Quality is at the forefront of our management group’s promise to design and manufacture product that is both safe and effective. Adherence to FDA and ISO Quality System requirements, as well as applicable product regulatory requirements, provides assurances to our customers that Optalmed takes our accountability to them and to their patients seriously.

Instilling a quality culture that our employees can not only follow, but help improve upon, promotes an environment of continuous innovation and progress.