Agile Medical Device Product Development

Design and product development expertise dedicated to medical devices, from idea to high-quality design, prototyping, commercial product and cost-efficient manufacturing.

Since 1994 we have specialized in medical technology services. Innokas’ engineering service offering covers all the aspects of product development, from idea conceptualization through device development and project implementation to transfer to production, and is always tailored to meet our customers’ specific requirements.

Our highly skilled engineering team includes all the necessary competences of product development, such as electrical and mechanical engineering, embedded software development, industrial and usability design, tester development, prototyping, verification and validation as well as quality, risk and project management.

Innokas engineers work under medical device design control process, which we have built to be compliant with the current medical device quality standards, regulatory requirements and directives (e.g. ISO 13485, FDA CFR 21 part 820.30 and MDD/IVD/AIMD).

"With the selected partners, the development of our new product will benefit from a very strong base of clinical and technical expertise."Andreas Mollat
Andreas MollatCEO, Otivio AS
“We at CareFusion really trust on Innokas’ knowhow and we can count on that their engineering professionals can cope with all QA/RA requirements well.”Janne Ranta
Janne RantaR&D Director, CareFusion Finland
"Innokas has experienced designers, who have participated in wide variety of medical system design projects. The co-operation with Innokas brings us new knowhow that we might not have in-house."Jarmo Ruohonen
Jarmo RuohonenDirector of Philips MR Therapy in Vantaa
"Innokas Medical has functioned as Modz’s external R&D department. The collaboration with Innokas Medical has gone smoothly, and Innokas has proved to be an important partner in the development of the blood sugar meter."Salla Koski
Salla KoskiFounder, MODZ
“Innokas’ project team worked systematically but flexibly with us. We were able to finish product development and transfer to manufacturing in record time thanks to close collaboration with Innokas team."Tapani Taskinen
Tapani TaskinenOwner, HLD Healthy Life Devices
"During this project we’ve been able to manage large and complex problems and I see that Innokas’ capabilities as well as knowledge has grown even further during the project."Juha Rantala
Juha RantalaProduct Manager, Innokas Medical Ltd.
"Innokas was chosen to be Bonvisi’s partner because of its longtime experience in medical device design as well as its very strong experience in QA/RA requirements. The cooperation between Innokas and Bonvisi has worked well."Anders Möllstam
Anders MöllstamManaging Director, Bonvisi AB
"Innokas was selected as the design partner especially because of Innokas’ experience and industry knowhow. In addition, Innokas had the engineers with appropriate technical backgrounds available for the project."Pasi Laukka
Pasi LaukkaProject Manager, Ajat

Engineering Service Offering

Engineering Services: Feasibility and concept studies

Feasibility and Concept Studies

Professionally evaluating the success potential of your idea, solving specific technical challenges and creating a roadmap for turning your R&D results into a medical or IVD product.

Engineering Services: Product development

Product Development

Designing a high-quality product that can be sold on the markets and manufactured cost-efficiently, and creating a required documentation according to Quality Management System.

Gaining market approvals and securing manufacturability with a properly designed and documented technical file.

Life cycle engineering of your product for improved quality and competitiveness, reduced costs and secured materials supply.

Engineering Services: Consultation services

Consultation Services

Risk Management: Supporting your project to achieve and demonstrate safety and effectiveness of your product according to ISO 14971:2012.

Usability: Improving the usability and safety of your product according to IEC 62366 in order to minimize risk costs.

Product Analysis: Analyze your product in order to improve e.g. design reliability, manufacturability and quality of technical file.

Engineering Services: On-site assignments

On-Site Assignments

A flexible way to deal with rapidly changing resource needs by strengthening your in-house product development projects with competent design experts from Innokas, even for short periods.

Innokas Engineering Locations and Competencies

Engineering at Innokas

  • ~ 60 professional engineers
  • Development projects according to ISO 13485 QSM and FDA QSR
  • Technical file (DMR, DHF) according to MDD/IVD/AIMD
  • Understanding EU harmonized and FDA recognized standards
  • Quality & Risk Management expertise
  • Regulatory intelligence and submission experience

Project Management

  • Following FDA-requirements
  • Following ISO 13485 requirements
  • Design for Excellence (DfX)

Software Development

  • According to IEC 62304
  • Embedded SW
  • User interface
  • SW testing, automated testing

Electrical Engineering

  • Real-time control boards, Digital IC design
  • Power electronics, high voltages
  • Design for EMC
  • Interfaces eg. wireless, USB, LAN
  • Battery technology, charging algorithms, wireless charging

Tester Design

  • Circuit Boards
  • Modules
  • Finished products

Mechanical Engineering

  • 3D Modeling
  • Complex plastic and metal design
  • Movements, mechatronics
  • Touch screen integration
  • Simulations

Usability Design

  • According to IEC 62366
  • Focus on usability and ergonomics
  • User interface and industrial design

Integrated design of system, electronics, mechanics and software in-house at Innokas – seamlessly working complete device efficiently!