RUSH, NY – June 2, 2016 – iuvo BioScience is pleased to announce that the Company has successfully completed a number of quality assessments and inspections, following a very busy month on the regulatory front.
Earlier in May, the Company participated in the ISO 13485 annual surveillance assessment at both facilities (the laboratory facility in upstate New York and the sterilization facility in northwestern Pennsylvania), which was followed shortly thereafter by the ISO 11135 annual audit. These assessments are part of iuvo’s continuous focus on the Company’s quality system. Both audits were successful because of the diligence practiced by the iuvo team.
In addition, the Company underwent an FDA inspection earlier this month. That process also went smoothly, as there were no 483 inspectional observations reported by the FDA.
iuvo is preparing for ISO 17025 testing laboratory accreditation, which is scheduled to occur next month, in June 2016. “Becoming accredited to 17025 will be a major milestone for us,” said iuvo BioScience CEO Ben Burton. “17025 is increasingly becoming the standard for laboratory services companies, and we are excited to add this to the list of accreditations and certifications that we currently have in place.”
iuvo’s Manager of Quality and Regulatory Tom Rizzo added, “The 17025 accreditation is additional confirmation that our laboratory has a high level of technical competence and we continually produce precise and accurate test data.” He went on to add that the full list of all accredited tests will be a part of the Company’s certificate which will be available on the Company’s website following successful completion of the accreditation process.
About iuvo BioScience
iuvo BioScience is a Partner Research Organization (PRO) serving the medical device and pharmaceutical industries. The Company offers technical and regulatory consulting services, contract laboratory services and contract sterilization out of its two locations, in Rush, New York, and Erie, Pennsylvania. More information on the Company’s services and capabilities is available on the Company’s website at www.iuvobioscience.com.