MDR Fast Track

Enable rapid market entry in a highly regulated domain by outsourcing your regulatory burden

Healthcare technology is in high demand to address the challenges of today’s healthcare, at the same time introducing new technologies is not easy. The entire process from an idea to a medical device on the market is heavily regulated and the path is laborious – especially for startups only building up their team and development processes.  We believe things can be made simpler – without risking the patient or end-user health and safety. The MDR Fast Track service for innovative MedTech companies was created to shorten and simplify the route to the medical device market and to a successful, growing business.

THE WHY

Accelerate speed to market

Reduce regulatory burden

Enable innovation and success

Mitigate overall business risk

Focus on your own core

Innokas Medical has an established and well-functioning QMS with all the necessary pieces in place, a growing team of highly experienced and passionate QA&RA experts along with well-oiled tools, practices and relationships with the relevant stakeholders, for example, notified bodies. You’re safe with letting us take care of the quality and regulatory requirements of medical device manufacturing. That’s something we have 30 years experience of.

We have a common mission. We believe that by enabling our customers to bring new technologies for the use of healthcare, we can improve the quality of people’s lives together.

With the MDR Fast Track service, you own your product and all intellectual property rights, and your solution is always sold under your brand.  Innokas will assume the role of a responsible manufacturer and fulfills obligations, and implements the MDR compliance. The service is always aligned to your specific needs, and the responsibilities are always agreed upon together with our customers. We will guide you through the process: all our expertise is in your use.

THE HOW

Mapping regulatory strategy

Product realization with Innokas’ expertise, tools and networks

Competitive advantage through market entry

Nurturing a profitable, successful, and growing business

THE WHO

The Innokas QA&RA team is here for you! The long experience in the medical regulatory and quality field enables the highly professional team to take the role of a forerunner in the medical device industry and steer you through to the market. Working together, sharing knowledge, and agility in adapting to change are our integral ways of working.

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CONTACT US

Are you developing a medical device or software as a medical device (SaMD)? To evaluate whether your solution would benefit from the MDR Fast Track, let’s set up a short consultation meeting. The fastest way to reach us is to fill out the contact form on the left. Send us a note and we’ll get back to you shortly.