We are striving to be the world’s leading in all our fields of expertise. Stay up to date for all that we share.
More about our way of working
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.
Delivery based projects
While working on projects we’re focused on delivery and results. That’s why each of our projects starts with a project charter or statement of work that serves all stakeholders and achieves results in due time. We apply project management methods in our projects. We prefer to work with clearly defined goals, scope (in/out), and jointly achieve the required results. By working together, we can make fixed price offers to identify deliverables and costs clearly upfront, prevent unpleasant surprises and guarantee results.
We can assist your organization in specific projects and topics such as how to comply with the standard of safety risk management, support for setting up a complete ISO13485 compatible quality management system from scratch, or extending an ISO9001 system.
Interim support
We deliver interim support for organizations needing specific resources for a longer period of time. We offer interim support for organizations that needs specific resources/knowledge and expertise for a longer period of time.
During your product development, we are part of your team in the role of MedTech expert. Our experts take the lead in the MedTech aspects of your project, and the team learns to use these tools and methodologies on-the-job.
The advantage of a Holland Innovative professional is that we continuously contribute experiences from other companies and projects, which speeds up your own development.
Consultancy
We can advise your organization in a consultancy role on specific topics, such as how to meet risk management standards. We also make gap analyzes to provide insight into what needs to be done to become ISO13485 certified. In addition, we perform in-depth analyzes related to the validation of your equipment. Whatever question you may have regarding the development of your medical equipment, we will do our utmost to solve it for you.
Coaching
We offer coaching if you need help with a project, want to reflect on a certain topic or challenge with an experienced sparring partner, or need support after completing a training to put what you have learned into practice. Our experienced professionals are also excellent coaches. We are here to support you!
Training
Our Holland Innovative Academy hosts several programs focused on Medical Device Development. All our courses are case based and directly related to daily work and projects. Each of our courses can also be taught in-house in your company, tailored to your specific topics and needs.
CE tool
In the light of sharing knowledge Holland Innovative has developed CE-tool, in collaboration with Panton and Fris&Fruitig. CE-tool is a web-based tool that guides medical devices manufacturers trough the process of CE-certification and risk classification by asking questions about the use of the device in various Quickscans.
Besides being trained in implementing a QMS according to ISO 13485, each individual HI team member has a strong background in physics, mechanical engineering, 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? Feel free to contact us!
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 lasting impact.
.jpg?width=200&name=Holland%20Innovative%20summer%20academy%20-%20Project%20Management%20Masterclass%202%20(2).jpg)
