We provide complete engineering and regulatory compliance solutions to companies, surgeons, or anyone wanting to get a medical device to market.

3D printing of components 

•  Product development from concept to end user

• Machine shop, injection molding, and cleanroom assemblies

• Concept Brainstorming & Product Development

• SolidWorks 2019 Modeling and Drafting

• FEA

• Prototyping

• Component Sourcing

• Specifications (Components & Assemblies)

• Verification Testing & Reports

• Packaging Design & Validation

• IP Research

• Documentation

• Quality System (Auditing, SOP Revision, Systems Implementation, Training)

• Design Validation

• Design Reviews

• Risk Analysis

• Design FMEA

Quality and Regulatory Affairs:

-Over 180 successful 510k Submissions & PMA’s

- International submissions and compliance, CE, EU, Health Canada, Australia, China

- CAPA

-Create and Review Product Change "Letters to File"


-FDA Facility Registration and Device Listing 


-FDA Good Manufacturing Practices (GMP), Quality System 


-FDA Quality System Audit Inspection Support 


-Medical Device Directive Compliance and Support 


-Medical Device Reporting and Complaint System Compliance 


-Quality and Regulatory Affairs Management


-ISO 13485-2016 Certification