Backed by a team of seasoned professionals specializing in various aspects of Quality and Regulatory domains, Innokas is prepared to support the market entry and compliance of your medical devices, medical software, or in-vitro diagnostic devices.
With our diverse team of experts from different professional backgrounds, we tailor our services to meet your specific needs. We work alongside you and your operations where you need it, be it one part of your journey or throughout the entire product life cycle and also empower your team with the knowledge and expertise needed to independently navigate these processes in the future.
We supply tailored regulatory roadmaps, device classification, and QMS development (ISO 13485, FDA, MDR/IVDR). Our services include gap analysis, mock audits, and team training to ensure compliance and readiness for audits.
We offer design phase support to ensure product compliance, usability, and risk management in alignment with MDR/IVDR standards. Our experts help you deliver safe, user-centered solutions while achieving regulatory success for medical software in healthcare.
We offer special expertise in clinical studies and biocompatibility for patient safety and compliance. Our team works hand in hand with you and provides guidance through clinical evaluations, assessing device impact, and ensuring biocompatibility at every stage of your project.
We assist in obtaining market approvals (CE marking, US FDA 510(k)) and provide post-market support, including surveillance, adverse events, and corrective and preventive actions to ensure ongoing product safety and effectiveness.
Scan through the case stories to learn about the versatile products and technologies we have worked with.
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Innokas’ QA/RA team is comprised of dedicated professionals with diverse expertise across multiple fields and backgrounds ranging from medical technology and software development to biochemistry and nursing. Our team thrives on collaboration, and we love working closely with our partners to understand their unique challenges and develop solutions that are right for them.
Our commitment is to ensure the development of safe, regulatory-compliant devices and solutions that improve people’s quality of life. The heart of our motivation is to make a meaningful, positive impact on people's health.
