Innova Medical Group is committed to providing high quality diagnostic products, at reasonable prices, to help counter disease outbreaks throughout the world. Founded in March 2020, Innova Medical Group has delivered over 1.5 billion lateral flow tests to our customers worldwide and is currently the world’s largest manufacturer of rapid antigen test kits.
“The team at Innova Medical Group does their best every day to assure our products provide high quality, repeatable and effective diagnostic results for our customers.” Doug Woodruff, Chief Officer, RA/QA/CA.
Since founding in 2020, the Innova team has put countless resources toward ensuring that our quality management system is compliant with both ISO 13485:2016 Medical Devices – Quality Management Systems, Requirements for Regulatory, and US 21 CFR Part 820 Quality System Regulation, Requirements for Medical Devices. At present, Innova is focused on international markets and is not manufacturing or marketing within the US.
Our adherence to these Quality Management Systems focuses our efforts on hiring knowledgeable staff, providing them with appropriate training, managing our processes with cutting-edge systems, and continuously evaluating our systems with internal and external assessments.
A Strong Quality Assurance/Regulatory Affairs Team
Innova has a large and dedicated Quality Assurance and Regulatory Affairs team consisting of leaders and team members, with expert knowledge and experience on quality and regulatory compliance matters. Innova is constantly expanding the QA/RA team to keep up with our US and global quality and compliance needs.
Continuous Training of Our People
Innova’s training program sets forth Innova’s procedures for identifying training needs. This ensures our personnel are adequately trained to better assure our products and processes are compliant with all applicable regulations. As part of our commitment, we use electronic training systems to track participation, completion and competence.
Conducting Internal Audits
Innova is committed to identifying improvements to our processes and product by regularly conducting internal audits to check our performance. Innova has completed many internal audits since inception and will continue doing so as part of its commitment to quality and compliance.
Implementing Additional Systems
Innova also has electronic Quality Management Systems in place to ensure quality policies are followed. We use Enterprise Resource Planning (ERP) systems to assure we have traceability of our products and that only the products that meet performance requirements are released.
Monitoring Product Performance
Innova continually monitors the performance of our products through diligent testing, oversight of our manufacturing processes and assessment of our Quality Management Systems by both internal and external assessors, as well as continuous monitoring and assessment of our customers’ experiences.