Presbia Achieves ISO Medical Device Quality Milestone
Presbia PLC (NASDAQ:LENS), an ophthalmic device company and leader in near-vision restoration, achieved a major milestone towards complying with the revised ISO (International Standards Organization) 13485:2016 by successfully completing the ISO 13485:2016 audit with no major findings.
- Presbia PLC (NASDAQ:LENS), an ophthalmic device company and leader in near-vision restoration, achieved a major milestone towards 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.
- 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.