Innokas Medical is a Finnish contract design and manufacturing organization (CDMO) specializing in high-quality medical devices. They offer comprehensive services from R&D and regulatory affairs to manufacturing and lifecycle management, serving a global clientele.

Medical Device Lifecycle Services

Innokas Medical provides full lifecycle management for medical devices, encompassing design, engineering, prototyping, and industrialization. Adhering to stringent quality management systems like ISO 13485, they ensure all manufactured devices meet high international standards. They offer scalable manufacturing solutions for various production volumes, partnering with companies to outsource their medical device production.

Regulatory Expertise and Quality Assurance

A key strength is Innokas Medical's deep understanding of medical device regulations, including EU MDR and FDA requirements. They assist clients with regulatory strategy, documentation, and submissions, navigating complex approval processes. Their commitment to uncompromising quality assurance is demonstrated through robust testing and continuous improvement, ensuring compliant and reliable products.