Presbia Achieves ISO Medical Device Quality Milestone
January 14 2019 - 8:00AM
Business Wire
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. 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.
About ISO 13485 Transition from 2003 to 2016
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, Sr. Vice President, 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.”
Forward-Looking Statements
This release contains “forward-looking statements” made pursuant
to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Information provided and statements contained
in this press release that are not purely historical are
forward-looking statements. These statements are typically preceded
by words such as “believes,” “expects,” “anticipates,” “intends,”
“will,” “may,” “should,” or similar expressions. Such
forward-looking statements only speak as of the date of this press
release and Presbia assumes no obligation to update the information
included in this press release. Statements made in this press
release that are forward-looking in nature may involve risks and
uncertainties, including, but not limited to, the factors listed
under “Risk Factors” in our annual report on Form 10-K for the year
ended December 31, 2017, quarterly reports on Form 10-Q, and other
reports that Presbia files with the SEC. Accordingly, readers are
cautioned that any such forward-looking statements are not
guarantees and are subject to certain risks, uncertainties and
assumptions that are difficult to predict. Although Presbia
believes that the expectations reflected in such forward-looking
statements are reasonable as of the date made, expectations may
prove to have been materially different from the results expressed
or implied by such forward-looking statements. Unless otherwise
required by law, Presbia also disclaims any obligation to update
its view of any such risks or uncertainties or to announce publicly
the result of any revisions to the forward-looking statements made
in this press release.
About Presbia
Presbia PLC (NASDAQ:LENS) 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. For more
information please visit: www.presbia.com
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Richard T. Fogartyrick@presbia.com949-502-7036