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We help customers – whether they are start-ups, small and medium-sized enterprises or multinationals – to organize their development processes in order to increase safety and reduce their risks.

Ivo Aarninkhof

Managing Director

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Professionals for Medical Device Development

Our experts can assist you in your medical product development journey. Being trained in observing and identifying your challenges from a fresh perspective, finding the best solution for your specific situation. It's our passion to bring your team and organization to a higher skill level in medical product development.

We strive to make an impact, and a permanent one at that. The complexity of your challenge and the dynamics of both the organization and the market require impactful solutions. Whether it’s a training, project management support or coaching on the job, we team up to share our knowledge for long term innovation success.

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Vital questions for the success of your medical device.

Are you aware of all applicable regulation and standards and well trained in these aspects?

 

Do you have a clear project timeline showing the correlation of all project competences, activities and deliverables?

Is your product developed in a structured and well documented way? According to the requirements of Quality Management Systems?


Is your team experienced in medical product development using the unique combination of regulatory, reliability, design for six sigma, data analytics and project management?

Our services.

How our experts can contribute to your organization.

Besides being trained in implementing a QMS according to ISO 13485, each individual HI team member has a strong background in physics, electronics, software, mathematics, technical medicine and biomedical engineering. We have learned that a combined approach of training, coaching and project participation increases involvement and accelerates impact. Curious about the impact for you or your organization? 
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In order to put good and safe products on the market, it is necessary to plan certain activities in time during the design and production process.

Lisette van Steinvoren – Stamsnijder

Competence Lead MedTech & Sr. Project Manager Medical

''For example, performing a risk analysis, writing a plan for testing the product, or a user analysis to determine the critical parameters for the product.''

Let’s talk about your challenge.

Our experience and excellence in the execution of our projects can help you to go further in your personal development and in the growth of your business.

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Ready to take on the next challenge.

Together with you, we face the challenge to share the future and take further steps towards value creation and social impact. 

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