Taking your medical device prototype to ISO13485 validated product launch
RD Support is a specialist company that bridges the gap between rapid prototyping and launching a mass-producible product.
You have identified a new market opportunity for a medical device and have taken it all the way to a feasible device.
You are now creating your Validation Master Plan and are talking to potential global manufacturers to manufacture your device for the market.
You have been highly innovative, agile and efficient with your money, but now you’re not finding any company to take on your project at the speed and budget you like.
This is because CMOs are great and cost-effective when the device design is frozen and validated and does not change anymore.
This is RD Support’s speciality.
Our Services
RD Support bridges the gap between innovative diagnostic development and mass production, offering a unique "fast and flexible" manufacturing model. Unlike traditional CMOs focused on high-volume, frozen designs, or legal manufacturers constrained by regulatory requirements, RD Support specializes in rapid iteration with daily changes while maintaining focus on ISO13485 certification.
With extensive in-house IVD and DFM expertise, production-quality toolmaking, and full cleanroom facilities, we enable seamless transition from development through clinical trials to commercial launch.
Providing the agility of a development partner you want with the quality standards of regulated manufacturing you need.
From medical device prototype to certified product on the market in 3 simple steps:
1 Design For Manufacture
We take your design inputs (the product specification) and run it through our proven DFM (design for manufacture) process to ensure that every component and every assembly step is scalable and cost effective in volume manufacturing.
2 Tooling
We’ll manufacture production-quality mould tools that we can modify every day if required. We update our cleanroom assembly equipment and adjust our processes to meet your throughput and quality expectations.
We send you development batches and make agile changes until the performance is right.
4 High Volume Production
Once on the market and production quantity ramps up significantly, we’ll transfer manufacture to your CMO of choice, if desired.
3 Manufacturing
We validate our component manufacture and assembly processes.
We produce verification and validation batches and documentation.
We deliver PQ (product quality) batches to support your regulatory approval and market supply.