The MedTech Lab consists of experts who have years of hands-on experience in complex, novel medical device development in a world class start-up environment.
We understand the challenges and constraints of a high tech start up.
We operate out of a local facility quipped with quality equipment typical of a medical device start-up laboratory.
This allows us to quickly take idea to prototype, sometimes within a single day.
If you have a facility space available, we provide services to outfit a laboratory to suit your operations. We are especially good at acquiring used but quality equipment to stretch your funding dollar.
We are familiar with the documentation required for proper design controls within a start-up.
We understand that it has to be lean but adequate enough to build a coherent Design History File (DHF) typically consisting a minimum of:
– User Needs, Design Requirements, Design Specifications Matrix
– Risk Management
– Design Reviews
– Development Plans
We aim to keep documentation burden to a minimum.
Quality Assurance (QA) and Research and Development (R&D) will always but in opposition with each other however it should not be in antagonistic.
You need a system that is compliant to the relevant standards, assures quality and especially device safety. However, it must allow for engineering to react to issues that will show up. We are of the opinion and have prior experience that developing a skeletal quality system from the ground up works best in a fast moving start-up.
Eventually, your start-up will grow to require production of units. Mostly, it will be low volumes for the first years. If by now you have insourced development and prototyping, you would have already developed the processes for building the devices hence it would be easy and natural to scale up and insource initial productions. We are able to provide support in the form of setting up audit/certification support, line setup, process development and production controls and documentation.