Professional Quality and Regulatory Services helping you to reach the compliance throughout the whole life-cycle of your Medical or IVD Device.

During regulatory framework creation, we offer clear and concrete advice enabling you to establish an optimal regulatory strategy and an efficient regulatory roadmap for your medical or IVD product. We help you create device concept analysis by defining the medical device classification and identifying all relevant standards and market specific requirements.

We help you map the regulatory requirements at an early stage to ensure the safety and effectiveness of your medical or IVD device. We help in the creation and completion of the technical file of your device according to Medical Device and In Vitro Device Regulations (MDR/IVDR) as well as relevant standards: e.g., risk management (ISO 14971), usability (IEC 62366), software lifecycle (IEC 62304), biocompatibility (ISO 10993-1) and medical electrical equipment (IEC 60601-1 including relevant collateral and particular standards).

Medical and IVD devices must comply with Medical Device Regulations (MDR) and In-vitro Device Regulations (IVDR). Are your company’s quality management system and products still far away from MDR / IVDR compliance? We offer our guidance to help you master your MDR / IVDR compliance to get your company and team prepared for the new requirements.

We support you in gaining market approval for your medical or IVD device in your target markets (like EU, USA, Canada, etc.). We guide you through the implementation of product-specific market approval and registration processes (for example 510(k) clearance) and support you in communicating with different regulatory parties. In addition, we assist you in updating your QMS processes according to market-specific requirements.

We help you establish practical and efficient QMS to suite your needs. We offer our guidance in improving and updating your processes according to different QMS requirements (like ISO 13485, US FDA, CMDR, MDR/IVDR, ISO 9001, ISO 14001). By gap analysis and mock audits, we can train your team and help prepare for the different regulatory audits.

Medical device manufacturers must follow certain requirements and regulations once devices are on the market. We have a unique service to manage the entire product life cycle, tailored specifically for medical and IVD devices. We provide our support to maintain and continuously improve your product and to also ensure the compliance of your product. We offer our guidance in your medical device post-market surveillance activities, for example adverse events, risk management, clinical evaluation, corrective and preventive actions.

We provide you a flexible way to deal with rapidly changing resource needs, even for short periods. We’re able to strengthen your in-house projects and complete QA/RA tasks with competent QA/RA specialist from Innokas – working at either your or our premises. We offer different services for different quality related tasks, for example internal audits, supplier audits, quality control in process validation, system tool validation, vigilance, post-market surveillance, QMS maintenance and quality managers or PRRCs for rent. The required specialist(s) will be selected from Innokas competence pool according to your needs.