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Tips available! How to ensure the regulatory compliance during the lifetime of a medical device?

When creating a new medical device to the market, there’s much more that goes into designing, developing and introducing it to the market. To be able to enter the certain markets, the development and...

Agile Medical SW Development – An Oxymoron?

The importance of SW is growing – also in medical devices and as medical devices. This blog text deals with the change of SW’s role, the tightening regulations landscape as well as how to be agile...

Co-creation across national boundaries – Samplix and Innokas Medical unlocking the genome with development of Xdrop™ instrument

Danish company Samplix ApS selected Innokas Medical to co-create the novel Xdrop™ instrument for droplet-based PCR-free enrichment of genomic regions.

The quality is built into daily work and operation at Innokas Medical

“At Innokas Medical, everything begins with the quality built into our processes, products and services. The most important know-how as well as the high standards of our daily operations can be seen...

Economically successful product means ensuring high quality as well as optimizing the total cost

Medical devices have remarkably important role in patient care. The key element in the sector is that there cannot be any compromises done with the safety and effectiveness of the devices – the...

Innokas Design Studio develops software for regulated medical devices to improve peoples' well-being

Healthcare technology is one of the largest high-tech export segments of Finnish industry, and the industry continues to grow strongly year after year. In addition to growth, development is also...

Tips available! Top four facts to consider when choosing your co-creation partner to design and develop your medical device

There’s a few common trends in the medical field, which have a clear effect to the development of new medical products. The first one is the constantly changing jungle of rules and regulations, which...

Top 10 benefits of applying appropriate Design Controls to your medical device development process

In short, Design Controls (or the practices of design and development as in ISO 13485) refers to the application of a set of formal quality practices and procedures to the conduct of product...

How effective tools, competences and ways of working can have an impact on achieving more agile development cycles for medical devices?

MedTech as business is changing and getting more complex. For example, the technical complexity and regulatory requirements are something that are increasing as we speak. In addition, the user...

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