Services

We are your go to full service provider for outsourcing medical device development. Our team of experts delivers on the highest possible standards in medical device engineering.

With a thorough understanding of how the medical device business ticks, we help you focus on selling and making profit.

Orthopedic design and technology of a new arm brace

Your full service provider

Innovate

We can maximize your impact

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R & D

We can develop your product

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Operations

We can supply your product

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Legal Manufacturer

We can handle your product responsibility

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Innovate

We can maximize your impact

How do you know which medical innovations are successful in the future? By asking smart questions, we find out together how to maximize your impact now and in the future.

R & D

We can develop your product

How to meet technical specifications? What regulatory pathway should be taken? We know all about design, engineering and validation, and understand what is needed to pass the notified body and the FDA.

Operations

We can supply your product

How to meet increasing requirements for product delivery? We streamline operations, ensure traceability and handle post market surveillance.

Legal Manufacturer

We can take responsibility for your
product

How to comply with the ever increasing demands from notified bodies? We take responsibility and can be your legal manufacturer.

How do you know which medical innovations are successful in the future? By asking smart questions, we find out together how to maximize your impact now and in the future.

Curious to what our customers think of our innovation service? Check out their testimonials on our projects page:

Projects

How to meet technical specifications? What regulatory pathway should be taken? We know all about design, engineering and validation, and understand what is needed to pass the notified body and the FDA.

Check which products we developed for our customers:

Projects

Find out more about our customers. We work for Multinationals, Distributors, Startups and more:

PARTNERS

Check out our latest interview ‘tips for medical startups’:

NEWS

Get answers on how to develop your medical device and obtain market approval on our Frequently Asked Questions page:

FAQs

How to meet increasing requirements for product delivery? We streamline operations, ensure traceability and handle post market surveillance.
We supply several products that we developed for our customers to these customers. You can find these products here:

Products

See what it implies to handle Operations on our Frequently Asked Questions page:

FAQs

How to comply with the ever increasing demands from notified bodies? We take responsibility and can be your legal manufacturer.
We are legal manufacturer for several of our customer’s products while our customers always hold IP. You can find these products here:

Products

See what Legal Manufacturing encompasses on our Frequently Asked Questions page:

FAQs

Take all hurdles with confidence

What experience do you have in medical device development? What investments are needed up-front and what is needed to expand your reach within the market? We know what is needed to develop a medical device, stand out and secure the path to succesful and profitable medical innovation.

Why outsource medical device development?

So you can focus on sales while maintaining flexibility. We will use our expertise in medical device development to get market approval for your device while you hold IP. Contact us today to use our solid foundations of experience and our established ISO 13485 quality management system.

Check also our Whitepaper on why it can be interesting for you to Outsource your Medical Product Development:

Contact
our expert

Medical Device Developer Dymphy

Dymphy van der Wilk – New Business Developer