Committed to quality in everything we do

Optim LLC is committed to quality and continuous improvement. All employees of Optim LLC are responsible participants in the quality improvement activities of Optim.

Our Quality Policy:

At Optim LLC, quality and safety are the foundation from which our company stands.  We strive to meet or exceed the needs of our customers through continuous improvement, while providing innovative and versatile solutions to our customers through our adherence to the highest quality standards.  Optim products are developed pursuant to a commitment to meet customer requirements.

While implementing its product development and customer satisfaction objectives, we commit to the highest standards of quality and safety for our customers, patients and employees by complying with all applicable regulatory and quality assurance requirements. Our Quality Management System will continue to be reviewed for suitability and maintained for effectiveness.


Our certifications:

Optim is an FDA registered manufacturing facility to FDA 21CFR Part 820 and complies with the MDD 93/42/EEC Annex VII through our authorized representative, Scanlan Group B.V.

Optim LLC is certified by Intertek Services Corporation to the following international standard | ISO 13485: 2016.