It all starts with a good design. Make sure your part is optimized for additive manufacturing following DFAM principles. Work with our team to define critical dimensions and tolerances. Consider reducing weight and cost by implementing lattice work. Need some help? You've come to the right place!
Work with us to establish the desired print orientation and support strategy. Then, we'll slice the part, and fire up the printer!
Inspect your parts. Understand the resulting geometry and determine whether or not it's acceptable.
It might take a few tries to dial things in. Update drawings and callouts to be sure things are just the way you want them.
Make sure your part performs the way it needs to when in use. Depending on your part, you might consider:
mechanical performanceChemical Compoisitioncleaning packaging sterilization transportationand beyond! Work with your FDA consultant to understand your unique product.
Your testing might indicate that some changes should be made. We'll go back to the drawing board to make it happen.
Our team will put together a design package ready for governing bodies to review as a supplement to your submission.
Already have a 510k? Send us your designs! We'll get started right away.
We'll create first articles of inspection. Make sure your parts are all good for testing.
Show equivalency to your current offering. Consider relevant areas of existing validations that will need to be revisited, such as chemical composition and mechanical performance. Work with your FDA consultant to understand equivalency requirements.
Sometimes things take a few tries. We'll go back to the drawing board and try again!
Our team will put together a design package ready for governing bodies to review as a supplement to your submission.
