Innokas

Lybe Scientific - How to build and deploy an efficient QMS with speed

Project timeline:

months

Service areas:

Quality and Regulatory

Written by

Last summer, Lybe Scientific got its first product registered as a CE-marked IVD medical device fulfilling the requirements set by In Vitro Diagnostic Directive (IVDD). The company built an ISO 13485 compliant QMS in a short time with the help of Innokas’ QARA team and got registered as a legal manufacturer of in vitro diagnostic medical devices. This was a key milestone for further sales and marketing of Lybe Scientific’s products for diagnostic purposes.

‍

Contact us

Lead Magnet: The 101 of medical technology innovation

Ask more about this project

Innokas highlights

Here you can find more of our latest news and insights in this category.

Innokas sustainability report launch

Introducing Valter Ritso, the new Director of Operations and Leadership team member at Innokas

Innokas Medical Rebrands as Innokas – Paving the Way for Growth and Innovation

Innokas highlights

Here you can find more of our latest news, tips and insights.

Getting the best return from prototyping

Efficient production transfer between factories

Why contract manufacturing?

How to find the elusive healthcare-certified software developer?

Innokas highlights

Here you can find more of our latest news and insights.

Case Terveystalo – Innokas software team helps develop medical software expertise

Case Nexstim – Familiarity with the sector and flexible operation gives a competitive edge

Case UKK Terveyspalvelut – Problem-solving skills and customer-oriented operation

Case MEGIN – Functional brain mapping by solutions based on magnetoencephalography technology

Innokas highlights

Here you can find more of our insights, news and tips.

No one builds alone – Contract manufacturing took the spotlight at Alihankinta subcontracting fair

Innokas challenges design thinkers to integrate circular design in healthcare

Arab Health 2024 – Our take and review

Innokas highlights

Here you can find more of our insights, news and tips.

Importance of hobbies in work-life balance – Insights from a Software Engineer

Europe's best – Innokas Medicals senior software engineer heading to Euroskills competition

Hire an International Student Campaign – Meet Ondra

Tomi Hugg is the new Director of Design Services at Innokas

Let's get started!

Contact us and find out what we can do for you.