Thunder Bay, ON (January 19, 2023) – Radialis Inc., a medical device company offering an FDA cleared Organ-Targeted PET Imager, announced today that the company has received ISO 13485:2016 certification for Medical Devices - Quality Management Systems. This certification is a requirement for regulatory purposes and is an international standard that outlines the requirements for a quality management system specific to the medical devices industry.
ISO 13485:2016 is an internationally recognized quality standard to ensure the consistent design, development, production, installation, and sale of medical devices that are safe for their intended purposes. To be certified, organizations must demonstrate their capability to provide medical devices and related services that consistently meet customer and regulatory requirements.
“I rely on ISO certifications to give me confidence in my supply chain. Now that we have it, I know it will give our customer base that same confidence in us.” said Ken Olsen, Director of Operations for Radialis. “This certification represents an important milestone for our company and reflects the focus we have on risk-based decision making throughout our organization with a commitment to providing a safe and dependable high-quality product every time.”
LRQA Inc. (formerly Lloyd’s Register Quality Assurance, Inc.) is the independent registrar that conducted the audit and authorized the certification. A PDF copy of Radialis Inc.’s ISO 13485:2016 certificate can be downloaded here.
Radialis delivers best-in-class organ-targeted positron emission tomography (PET) medical imaging systems. Radialis’ facility for advanced manufacturing of medical devices is in Thunder Bay, Ontario.
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