ONE-STOP MEDICAL DEVICE DEVELOPMENT COMPANY
FROM CONCEPT TO A WORLD-CLASS MEDTECH PRODUCT
Share your idea. As MedTech engineers we get it done!
What clients say about us?
Since June 2022, we have been working with Consonance throughout the development process up to and including the BC-1 medical devices manufacturing. Their knowledge in the technical and regulatory field has been a huge gain. The agreed deliveries: time, quality and price have been delivered without deviation. We expect to continue our cooperation.
QA Manager
BrainCapture
Denmark
“We worked together with Consonance to prepare functional prototypes of our impedance spectrometry and anal probe, the main parts of the ONIRY product. The cooperation was very good, the project was perfectly managed and communicated, all work went according to the schedule. We are fully satisfied.”
PhD, CEO
OASIS Diagnostics
Poland
"Consonance exhibited a high level of expertise, demonstrated exceptional organizational skills and a highly structured approach in conducting the feasibility study. The result they provided was not only thorough but also actionable, laying a solid foundation for the subsequent stages of the prototype development."
MD, PhD
Charite
Germany
Our Clients
MedTech insights
6 Big Questions to your MedTech Manufacturing Partner
Finding a compatible, friendly, and expertised MedTech manufacturing partner might be harder than reading color codes on tiny resistors – we get it. There are hundreds of potential subcontractors out there, and each of them probably claims to suit your requirements one way or another.
Medical Device: What Makes a Clinical Need Worth Solving?
Before you invest your time, money, and effort in a medical device, it is crucial to find out whether this exact clinical need is actually worth solving. The overengineering trap has led many MedTech startups to fail. It is relatively common to create an innovative technology and focus entirely on developing it using public grants in most cases in the EU. The question: “is there a real clinical need for my solution?
FDA & MDR: The Real Difference of Medical Device Risk Classes
Let's face it: in MedTech it always comes down to proving your product is both safe and effective. Period. To do that, you must precisely identify which of the medical device risk classes your product applies to. These classifications are dictated by specific authorities, which differ for each region – such as the Japanese PMDA, Health Canada or the U.S. FDA and EU MDR. In this article we will focus on comparing the latter two and answer some burning questions