Design and product development expertise dedicated to medical devices and solutions.

Are you looking for a partner to evaluate the success potential of your idea? Let’s develop your business case, sharpen your concept and validate the feasibility of your idea!

During Concept Elaboration, we investigate the potential of your idea in your target markets, validate your business and potential risks, and verify the technology choices and regulative feasibility. During Concept Validation, we implement iterative prototyping to verify that the concept has practical potential, including the validation of the feasibility together with the end users. Commercialization Roadmap creation helps you to create the initial budgetary estimate, regulatory framework and program plan, ready to be presented to various stakeholders.

Are you looking for a partner with whom to co-create your medical device or who can update your existing product? Let’s innovate and execute faster by co-creating together!

Our cooperation can be anything from Turn-Key Product Development projects – including concept clarification, prototyping, design & development according to ISO 13485 QMS and FDA QSR, technical file creation (DMR, DHF) and verification & validation – to Design Renewal projects, aiming for improved quality & competitiveness, reduced costs and secured materials supply (REACH, RoHS etc.). The project plan and the needed team of specialists will be built according to your needs. You’ll have a validated end-product that meets the regulatory requirements & quality standards of your target markets, and can be manufactured cost-efficiently.

Do you have changing needs in your medical device design & engineering or quality & regulatory management, and have difficulties in finding the right talent in right time? Let’s reach the next critical milestone in your device roadmap together!

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 product development projects with competent design and QA&RA experts from Innokas – flexibly working either at your or our premises. The needed team of specialist(s) will be selected from Innokas competence pool according to your needs.

Are you looking for experienced consultants to match your missing project preferences? We provide clear and concrete consultation enabling you to reach your targets.

As an example, during Design Controls project, we help you to establish effective design controls fulfilling the regulations. In Risk Management consultation, we support you in achieving and demonstrating safety & effectiveness of your product according to ISO 14971. We understand the essence of usability in medical device development and provide Usability consultation to help you improve the safety and effectiveness of your product according to IEC 62366. During DfX Feasibility Studies, we create the recipe for your high-quality and economically successful product while optimizing its manufacturability & design reliability. These are only a few examples – you name your targets, we reach them together!