Founder Karen A. Iorio is a problem-solving, collaborative and business-minded Quality Assurance and Regulatory Affairs Executive with over 15 years of experience in the regulated medical device and medical device software industries. She is experienced in leading small, mid and large size multi-national organizations. She has established a track record of developing robust Quality Systems and continual improvement programs proven to be in compliance with the FDA’s Quality System Regulation, ISO 13485, ISO 9001, EU’s Medical Device Directive, Canada’s Medical Devices Regulations, ISO 62304, ISO 14971, IEC 60601 and other global compliance requirements.
Karen has proven leadership skills, providing guidance and oversight to product development, manufacturing Quality Assurance Operations and other cross functional groups, along with global regulatory compliance and approvals. She is an ASQ Certified Quality Auditor. Karen also possesses solid interpersonal skills and collaborates successfully across all levels of an organization, as well as with external regulatory agencies and healthcare institutions.