Novem Medical, an ISO certified 13485:2016 company, works in tandem with Medical Device Companies to help bring their products to market
*FDA registered and ISO 13485:2016 business
Our wide range of expertise allows us to assemble Class 1 and 2 devices.
We offer our decades of experience to help navigate quality, regulatory and engineering bottlenecks.
Our relationships with manufacturers help us work through the complexities of various device applications.
At Novem Medical, we offer an extensive range of ready-to-use processes and state-of-the-art machinery, ensuring efficient and reliable solutions for your medical device needs. Additionally, we specialize in providing custom turnkey solutions tailored to your unique product requirements, from concept through to market launch.
Customer defines project scope and provides boms and drawings.
Novem Medical provides a proposal.
Customer accepts proposal and signs quality agreement and contract
Novem Medical generates Master Validation
Once all reports have been approved, Novem Medical begins production.
Check out our recent blogs to stay updated on the latest advancements in medical protective gear and industry best practices.