There is a lot involved in the development of new medical products or software. The developers of the CE tool (Panton, Holland Innovative and Fris & Fruitig) not only have a lot of knowledge of CE regulations but can also help you with other parts of the development.
Feel free to contact one of our experts to discuss what they can do for you.
Ease of use is an important success factor for the adoption of new technology. Healthcare technology must be easy to use for all target groups and fit into the work and care process. Panton's designers specialize in shaping technology such a way that it is embraced by patients and caregivers. Panton can help you with the development of the look & feel of new products as well as with the technical development of your products. All this within the framework of the applicable CE regulations.
Would you like to know how we can support the development of your new technology in such a way that patients and healthcare providers want nothing more than to use your technology? Take a look at the Panton website for inspiring examples or contact Mario de Zeeuw.
To ensure that medical products are safe and reliable, medical legislation requires manufacturers to have a quality management system according to ISO 13485. The QA/RA specialists of Holland Innovative have years of experience in tailoring quality management systems for medical device manufacturers. After all, a small startup has very different needs than an SME or multinational. Our HI basic-QMS consists of pragmatic procedures and templates that have already undergone dozens of ISO13485 audits under the MDR and IVDR. We can implement the QMS with you, train your quality manager, and train the team in the use of the QMS so that all your medical products are of constant and high quality. Our goal is to build a pragmatic, workable QMS for every organization!
Would you like to know how we can support you in setting up and implementing your quality management system? Take a look at the website of Holland Innovative or contact Lisette van Steinvoren.
More and more devices used in healthcare contain software or consist only of software. This applies both to specialistical medical devices and to devices that patients use to monitor their health (at home) or to stimulate healthy behaviour. A simple and friendly user interface (UX) is of great importance here. Panton's designers specialize in designing user interfaces that meet the needs and possibilities of different target groups. After all, a user interface for highly educated medical professionals requires different solutions and design than a user interface for less digitally skilled older people. We support you in the development of a user interface that suits your target group and complies with medical CE regulations.
Would you like to know how we can support the development of medical software or health apps, in such a way that it is tailored to your target group? Take a look at the Panton website for inspiring examples or contact Mario de Zeeuw.
Clinical studies are necessary to demonstrate the safety and functionality of medical devices in a real clinical environment. Because the safety of the product has not yet been proven, but people will be exposed to the product, a manufacturer must comply with many rules before he can start a clinical trial. An MREC often requires approval, and all the necessary documentation must be drawn up. Within Holland Innovative we have BROK-certified QA/RA managers who can support you in setting up your clinical trial so that it meets all the requirements of the law.
The MDR prescribes that a medical device must be safe, including during use. To comply with this, the standard for usability engineering, IEC 62366, can be used. This standard requires usability evaluations to be done. Formative and summative evaluations can be set up and carried out according to this standard. Panton's designers have extensive experience in setting up, carrying out and documenting usability studies. They can even help you set up the usability engineering procedures within your organization to safeguard the usability engineering within all your development processes.
Would you like to know how we can support you in setting up and carrying out your usability engineering studies? Take a look at the Panton website for inspiring examples or contact Céline Joosten.
The world of medical legislation and regulations is complicated and can be a tangle of information and documents for a newcomer. Our training courses Fundamentals of Medical Device Development and CE certification of your (IVD) medical device, help you find your way around this.
In our training Fundamentals of Medical Device Development we take customers through the development process of a medical device in three days. At Holland Innovative, we believe that the combination of knowledge about laws and regulations, statistically based design choices (design for six sigma) and project management is the link to fast and reliable product development. With one day dedicated to each topic, the FMDD provides you with a good foundation to get started with medical product design.
The CE certification training of your (IVD) medical device provides an overview of all major topics of medical laws and regulations in 1 day. MDR/IVDR, quality management, risk analysis and setting up a technical file are discussed in a nutshell, interspersed with exercises to provide insight into the theory.
Curious about our training courses? Take a look at our Academy website or contact Irene van den Graven.