Rapid Prototyping
Support idea generation with rapid prototyping, feasibility studies, etc.
Portfolio
Design Reviews
Support conception with design reviews, product layout, risk management, requirements engineering, proof of concept
Quality Management
Build the quality management system, proper documentation / development file (DHF, STED)
Support medical studies
Support for medical studies, certifications, post market surveillance, vigilance systems, etc.
Product Development
Embedded Systems Engineering, Mechanical Engineering and Automation, Software and Quality Engineering
Milestone Planning
Project management, including milestone planning, risk management, etc.
Startup Support
Startup support (e.g., pitch deck development)
Medtech Innovations
Independent implementation of medtech innovations across all development steps
You want your visionary idea for an innovative medical product to be implemented quickly and profitably. Great!
Truly: this is not easy. Because the path from product idea to prototype to series production readiness for medical products is an almost impenetrable jungle of regulatory requirements, approval procedures, technological tough nuts, and other challenges.
Orientation of requirements
For medical products, the development project must be aligned with the applicable regulatory requirements right from the start. This is the only way to avoid costly mistakes and lengthy delays.
konplan helps you pave the shortest and safest path through the medtech jungle: Together, we will develop the best solution for your product, master the regulatory obstacles, launch into production quickly and safely and provide optimal service to your customers.
We have detailed knowledge of all the necessary steps towards market approval. We know the specific requirements related to product development, documentation, surveillance, etc. Because of our experience, we understand the typical “pain points” of medical product development and will help you avoid many stumbling blocks and pitfalls.
Connect to our network
You also benefit from our network. We provide connections to essential partners, bring you in contact with the relevant institutions and test laboratories of our network and, upon request, recommend suitable companies for series production.
We are here for you – send us your request!
Developing together! We put your ideas into practice and accompany your projects until they are ready for the market. Get in touch with our experts now.
Learnings
References
Development of a new type of eye laser
Pantec Biosolutions AG, a MedTech company in Liechtenstein, is developing an advanced eye laser (class IIb) for a US start-up which integrates a new treatment method for presbyopia.
Software development for an eye laser according to IEC 62304
A medium-sized Swiss MedTech company develops and markets innovative products for the diagnosis and treatment of eye diseases using a new type of eye laser.
Product Life Cycle
