Our experience in industry showed us a significant challenge faced by many of you when launching a medical device: the lack of experienced launch partners able to meet (or beat) timelines. This gap inspired us to develop a system of proven validations and related services that get you to market faster. A lot faster.
A successful launch starts with a meticulous plan. Our team partners with you to identify critical-path points. Our project management approach implements the plan, while our industry knowledge spots and implements schedule improvements.
Sterilization methods must account for all materials, exposures and states. We validate and prepare your gamma, E-beam and EO sterilization protocols, to ensure your success.
When you are trying to launch, getting a small lot manufactured can be a challenge. Who will do it? SmartStart will. We are ISO 13845 accredited and are experts at pilot batch productions to prove your readiness for launch.