Presbia Achieves ISO Medical Device Quality Milestone


DUBLIN—Presbia PLC (NASDAQ:LENS), an ophthalmic device company and leader in near-vision restoration, achieved a major milestone toward complying with the revised ISO (International Standards Organization) 13485:2016 by successfully completing the ISO 13485:2016 audit with no major findings. This was an essential step in recertifying under the ISO standard with annual surveillance audits for the next two years. The renewal of the company’s CE Mark has been completed and is valid through 2022. Notified Body NSAI (National Standards Authority of Ireland) conducted the audit.

In February 2016, the International Standards Organization (ISO) revised its medical device standard, ISO 13485:2003 to ISO 13485:2016, placing greater emphasis on medical device quality management systems (QMS) in all aspects of product lifecycle. The revised standard provided for a three-year transition period for medical device organizations to achieve compliance with ISO 13485:2016.

Bob Lundberg, SVP, Regulatory and Quality of Presbia, said, “We are extremely pleased that we achieved recertification under ISO 13485 during the transitional period, and it further demonstrates our commitment to quality in all aspects of our business.”