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Ready or not - the new European Medical Device Regulations (MDR) are coming!

The new Medical Device Regulations (2017/745/EU) (MDR), published in May 2017, will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices...

Ensure the quality compliance of your medical device – learn about the regulatory process in practice

Do you have an idea of a medical device? Or have you already started to develop your medical device? Do you want to enter, e.g., EU or US markets?

FAQs about quality compliance and regulatory affairs in medical business

Finding answers? Welcome! - This is an unofficial guidance which is intended to assist medical device OEMs by answering to some common and basic questions concerning quality compliance and regulatory...

Achieve more agile medical device development cycle by putting more effort on the idea phase

There’s 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...

Quality Management System - one key to success

When you’re working in medical industry, it’s a fact that regulations and standards are something that companies need to follow and they’re coming stricter for everyone continuously. This is...

An agile co-creation of next generation medical devices – Innokas launches the MedTech Design Studio

Innokas Medical renewed its strategy during the last year, aiming to achieve the company’s new vision and to take the changes of the operative environment as well as the development needs of the...

Collaboration between Innokas Medical and Kasve - promoting the success of medical device OEMs in the market

 Innokas Medical and Kasve Ltd. have agreed on strategic partnership in Nordic countries. Kasve is a Finnish expert service company located in Kuopio, focused e.g. on the quality and regulatory...

Tips available! How to balance the regulatory compliance with medical device design and development process?

When creating a new medical device to the market, there’s much more that goes into designing, developing, and introducing a medical device to the market than simply coming up with an innovative idea,...

Why you should care about rules and regulations in medical business?

Bringing a medical or an IVD device to market can be a nightmare of confusing regulatory standards and regulatory authority certifications that must be complied with and which must be integrated into...

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