Cost-efficient Contract Manufacturing of Medical Devices

On-time delivery, highest quality and flexibility to adjust to your market and product needs.

Since 1994 we have specialized in medical technology services. Through our 25 years of experience in the MedTech field we’ve gathered extensive knowledge in medical and IVD device manufacturing in our ISO 13485 compliant and FDA registered facilities.

Our manufacturing operations service offering covers all the phases of medical and IVD device manufacturing, from design transfer and production process validation to manufacturing – that is been carried out according to ISO 13485, GMP,

CE, Health Canada and FDA requirements – and to the product life cycle management activities that regulations require.

Our three production plants allow us to provide our customers flexible production capabilities and manufacturing volumes, ranging from few systems per year to thousands of units per month, so we are able to operate perfectly according to our customers’ market demand. Our production lines are always tailored specifically according to our customers’ needs.

Innokas manufacturing process has ISO 9001:2015, ISO 13485:2016 and Canada ISO 13485:2003 certifications and it also complies with FDA regulations. Our manufacturing process has been fine-tuned especially for medical and in vitro diagnostic devices and high level assembly production, comprising devices from hand-held to table-top units and even to complex diagnostic systems.

“Innokas has very talented team, the industrial and quality know-how as well as the experience in manufacturing health technology products that we need."TImo Hilden
TImo HildenFormer CEO, Icare Finland
"We’ve been very satisfied with the co-operation with Innokas from the very beginning. Reflecting on the supplier evaluation performed by us, Innokas was selected as the best alternative to manufacture our products." Tim Thurn
Tim ThurnCEO, C-RAD AB
"Innokas Medical manufactures Relaxbirth’s Birthing Support devices. The collaboration has been excellent between Innokas and Relaxbirth."Jukka-Pekka Luostarinen
Jukka-Pekka LuostarinenFormer CEO, Relaxbirth
"Innokas Medical’s operation has been rapid and of high quality. An especially valuable characteristic that comes to mind is Innokas’ ability to give us feedback about assembly instructions and technical issues, as this will help us in further developing our product."Jani Virtanen
Jani VirtanenFormer COO, Sooma
"Innokas has been responsible for manufacturing, further development, and component purchases of the blood sugar meter. Innokas was not the least expensive, but we chose it because of quality factors."Salla Koski
Salla KoskiFounder, MODZ
"In addition to design and development as well as manufacturing services, Innokas Medical’s very strong quality and regulatory experience is something that has bring us added value.” ”Janne Matikainen
Janne MatikainenProduction and Logistics Manager, Lymphatouch Oy
"Manufacturing of the Carescape VC150 Patient Monitor has started in Innokas’ Tallinn low cost factory, and Innokas is also taking care of the maintenance and after sales support of the device, as well as spare part managing and service training."Sami Pakarinen
Sami PakarinenProduct Manager, Innokas Medical Ltd.
“Our mutual journey has been a good one. Innokas Medical has the industrial know-how and experience in manufacturing health technology that we need."Jonas Karlström
Jonas KarlströmSenior VP, Elekta

Manufacturing Operations

Service Offering

Innokas Medical has created well-defined and structured service packages, which are designed and targeted for each phase of medical device manufacturing.

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Supply Chain Management

Suppliers are selected from Innokas’ qualified supply chain, and competitive material costs are negotiated.

Spare parts are stored in customer’s own storage place in our factory storage.

Obsolescence components announcements and evaluation given to customer following our obsolescence component process.

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DfX Feasibility Study

Create the recipe for your high-quality and economically successful product while optimizing its life-cycle costs.

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Design and Product Transfer

Reliable design transfer to manufacturing with our in-house engineering, sourcing and manufacturing experts.

Professional NPI-process for ISO 13485 and FDA compliant manufacturing.

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PWBA Manufacturing

Manufacturing volumes according to your demand, and guaranteed quality of PWBA’s including reliable testing.

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Final Assembly

On-time delivery of high-quality final products, flexibly according to your demand.

ISO 13485 and FDA compliant final assembly with proven traceability.

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Warehousing & Logistics

Warehousing of the finished products and shipping to the specified destinations by using cost-efficient turnkey logistic solutions.

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Post Production Activities

A unique service by managing product’s entire life cycle that is tailored specifically for medical devices.

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Design Renewal

Our experts help to specify how to improve the existing design to meet the new needs for improved business performance and guaranteed compliance.

Innokas Manufacturing Locations and Competencies

All Sites

  • Personnel ~120
  • ISO 13485 certified
  • FDA registered and Innokas QMS FDA inspected
  • Manufacturing processes follows IPC standards as well as ISO 13485 and FDA GMP requirements
  • All sites work under the same Quality Management System
  • Audited and controlled network of suppliers

Kempele

  • Floor area 3000m2
  • Prototyping
  • Ramp-up production
  • SMD manufacturing
  • Final assembly and testing
  • Decontamination room
  • Environmentally controlled production
  • Maintenance

Helsinki

  • Floor area 1200m2
  • Challenging manual assembly of electronical and mechanical components (e.g. bonding, micro mechanics, cryo/vacume technology, gases and liquids, magnetism)
  • Environmentally controlled room
  • Final assembly and testing
  • Field installation & maintenance

Tallinn

  • Floor area 1500m2
  • Low cost option for high- and medium volumes
  • Environmentally controlled room
  • Final assembly and testing
  • Maintenance

Finding new partner to manufacture your medical devices? Choose the most optimal one providing most value to your business!

If you are finding a partner to cooperate with, it cannot be stressed out too much that it really matters which kind of cooperation partner you choose to manufacture your medical devices to the market. The domain specific expertise, related competences and strong quality and regulatory expertise of your partner is something that really matters. Choose the one with more clearer benefits and more added value for your business.

We see that it is also very important that your partner is able to show you in a concrete way how they can help you to solve your problems and how they can improve your company’s business situation. As an example, please see below a framework we’ve created to illustrate that.

This framework illustrates the additional benefits Innokas Medical is able to offer to customers through our domain specific expertise and related competences. We think this kind of illustration is an ideal way to visualize the added value and concrete benefits the partner can offer through its expertise besides the core solution.

The base for this is our comprehensive and scalable service portfolio which makes us unique. It spans over the entire product life cycle. Our cross-functional team ensures seamless progress from idea to design implementation, then through design transfer to manufacturing and finally to life cycle management. Early involvement of Design Studio, Manufacturing Operations and QA&RA guarantee that all the quality and regulatory requirements as well as design and manufacturing needs are covered. This speeds up the time to market launch and reduces the total cost.

Do you want to hear more or discuss with our professionals? Let’s talk! Click here to leave us your message, and we will get back to you shortly!