Medical device design.
Medical device design requires a more structured approach than most product development. Every decision must consider patient safety, risk management, and regulatory compliance from the start. We help startups build with verification and clinical readiness in mind, so innovation can move forward confidently toward approval and real-world use.
Where early stage startups can get stuck
Where early stage startups can get stuck
Where early stage startups can get stuck
As an early stage medtech startup, there are many uncertanties that can make make the process seem daunting:
As an early stage medtech startup, there are many uncertanties that can make make the process seem daunting:
Understanding complex FDA/ CE regulatory guidlines
Understanding complex FDA/ CE regulatory guidlines
Understanding complex FDA/ CE regulatory guidlines
Struggling to produce realistic and effective MVPs
Overlooking manufacturability and cost early on
Struggling to produce realistic and effective MVPs
Overlooking manufacturability and cost early on
At IMME we offer a structured, six-step development framework which takes you from idea to manufacturable prototype, while considering cost, time to market and regulatory compliance from the outset.
At IMME we offer a structured, six-step development framework which takes you from idea to manufacturable prototype, while considering cost, time to market and regulatory compliance from the outset.
Medical Device Development Framework
An end-to end process for developing capable and compliant medical devices.
Medical Device Development Framework
An end-to end process for developing capable and compliant medical devices.
The power behind our framework.
The power behind our framework.
Our framework is based on four principles that are observed in every IMME project. Click below if you want to see the specific services we employ them in.
Our framework is based on four principles that are observed in every IMME project. Click below if you want to see the specific services we employ them in.
Speed with Structure
Bringing the agility of our team to your production process.
Speed with Structure
Bringing the agility of our team to your production process.
A Complete Package
Every aspect of your project considered, designed to perform seamlessly together.
A Complete Package
Every aspect of your project considered, designed to perform seamlessly together.
Regulation at the Heart
Compliance integrated from the outset, letting you rest easy.
Regulation at the Heart
Compliance integrated from the outset, letting you rest easy.
Scalability Baked In
Ensuring your device is designed with future-proofing in mind.
Scalability Baked In
Ensuring your device is designed with future-proofing in mind.
Speed with Structure
Bringing the agility of our team to your production process.
Regulation at the Heart
Compliance integrated from the outset, letting you rest easy.
A Complete Package
Every aspect of your project considered, designed to perform seamlessly together.
Scalability Baked In
Ensuring your device is designed with future-proofing in mind.
Do you have questions about our services?