Business Wire02.25.19
Presbia PLC, 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. 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. The most significant changes between the original and revised standard include:
Bob Lundberg, senior vice president, Regulatory and Quality, at 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.”
Presbia PLC is an ophthalmic device company that has developed and is currently marketing the presbyopia-correcting Presbia Flexivue Microlens, a miniature lens that is implanted in a corneal pocket created by a femtosecond laser. The Presbia Flexivue Microlens has received a CE mark for the European Economic Area, allowing the lens to be marketed in over 30 countries across Europe. A staged pivotal U.S. clinical trial for the Presbia Flexivue Microlens commenced in 2014.
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. The most significant changes between the original and revised standard include:
- Use of risk-based approaches in the context of the safety and performance of medical devices meeting regulatory requirements;
- Additional emphasis on complaint handling and reporting to regulatory authorities;
- Increased emphasis on documentation of corrective actions and preventive actions without undue delays;
- Increased linkage with regulatory requirements and related documentation;
- Increased focus on production of sterile medical devices and related sterile barriers in production; and
- Validation of software, production and supply-chain processes.
Bob Lundberg, senior vice president, Regulatory and Quality, at 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.”
Presbia PLC is an ophthalmic device company that has developed and is currently marketing the presbyopia-correcting Presbia Flexivue Microlens, a miniature lens that is implanted in a corneal pocket created by a femtosecond laser. The Presbia Flexivue Microlens has received a CE mark for the European Economic Area, allowing the lens to be marketed in over 30 countries across Europe. A staged pivotal U.S. clinical trial for the Presbia Flexivue Microlens commenced in 2014.