Professional Quality and Regulatory Services guiding you to master your medical- and IVD device compliance journey.

Medical device manufacturers must comply with MDR by May 26th 2021. Get your company and team prepared for the new requirements and for the stricter rules of Software as a Medical Device before the MDR takes effect. We offer you our guidance to help you to master your MDR compliance journey.

During regulatory framework creation, we offer clear and concrete advices enabling you to establish  an optimal regulatory strategy and an efficient regulatory roadmap for your product. Tasks and deliverables include, e.g., market area requirements setting, device qualification & classification, applicable standards analysis and clinical roadmap analysis.

We have years of experience in application of different QMS requirements to many kinds of manufacturers, products and technologies, and in different QMS certification processes. We help you to establish practical and efficient QMS which suite your needs. Tasks and deliverables include, e.g., quality management system planning and establishment, MDR and/or 510(k) gap analysis and mock audits.

We help you to map the regulatory requirements at an early stage to ensure the safety and effectiveness of your medical- or IVD device. Tasks and deliverables include, e.g., technical file creation (DMR, DHF) according to MDR/IVD/AIMD, risk analysis according to ISO 14971, usability consultation according to ISO 62366,  clinical evaluation report (CER), technical reviews and mock audits.

Different market areas have different requirements. We help you to bring your medical or IVD device to the market by helping you to gain market approvals for your target markets (CE, MDSAP and 510(k) programs as an example).

A unique service to manage product’s entire life cycle, tailored specifically for medical- and IVD devices. The product is continuously kept up-to-date regardless of a long life cycle. We provide our support to upkeep and to continuously improve your product and procedures. Tasks and deliverables include, e.g., retrospective design history remediation and internal auditing.

We provide you a flexible way to deal with rapidly changing resource needs, even for short periods – to speed up your development cycle. We’re able to strengthen your in-house projects with competent QA&RA specialists from Innokas – working either at your or our premises. The needed team of specialist(s) will be selected from Innokas competence pool according to your needs.