LightDeck Diagnostics Earns Certification to ISO 13485
Certification affirms the Company’s Quality Management Systems meets ISO, FDA, and Health Canada Requirements
Boulder, CO.November 20, 2020 – LightDeck Diagnostics announced today the certification of its Quality Management System to ISO 13485:2016 / MDSAP (Medical Device Single Audit Program). This certification is an important milestone, particularly as the Company prepares for commercialization and scales production of the LightDeck COVID-19 Total Antibody Test, its first in vitro diagnostic product.
ISO 13485:2016 specifies requirements for a Quality Management System where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. The MDSAP covers regulatory requirements for the US and Canada through a single audit and opens the door to add geographical regions as business needs require. Certification to ISO 13485:2016 is also the first step in achieving compliance with European regulatory requirements that must be met before sale is permitted.
“On the heels of our Series B fundraise, this certification testifies to our commitment to quality and takes us one step closer to development and commercialization of our in vitro product suite,” explained Chris Myatt, CEO and Founder of LightDeck Diagnostics.“
The audits involved adapting to a mixed on-site and virtual process due to the COVID-19 pandemic, a testament to the flexibility and commitment of the team.
About LightDeck Diagnostics
LightDeck Diagnostics believes in a new approach to healthcare, where quick and accurate diagnostic tests will be run wherever and whenever they are needed, without compromise. The company’s proprietary LightDeck® platform combines an advanced laser waveguide with novel materials and patented manufacturing techniques to deliver lab-quality results anywhere, in minutes. LightDeck is introducing a portfolio of in vitro diagnostic panels, the first is an on-the-spot test for COVID-19, followed by highly accurate, host-response panels to manage acute infections and sepsis, and next generation tests for heart attack triage. The LightDeck platform is also achieving success in veterinary diagnostics and for environmental testing. Learn more at www.LightDeckDx.com
About ISO 13485: 2016
ISO 13485:2016 is an international standard, globally recognized for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical devices. ISO 13485 is based on quality management principles that have been proven to enhance organization performance. These principles relate to customer focus, management, internal processes and external relationships.