Medical Device Innovation

Concept to Commercialization

Resolution Medical, LLC designs, develops, tests, and manufactures medical devices and components in collaboration with its customers.

Facilities
Development and Manufacturing Center
– Minneapolis, Minnesota
- 10,000 ft2 newly renovated facility with expansion rights
– Engineering, development and manufacturing
- Certified Class 10,000 Clean Room

Key Capabilities & Expertise
– Vascular, Neuromodulation, CRM, Urology, Cochlear and Orthopaedic Product Expertise
– Clean Room Device Assembly, Testing and  Packaging
– Adhesive Bonding, Curing
, UV Curing Systems
– Soldering, Laser and Resistance Welding
– Thermoplastic Injection Molding
– Pad Printing and Silicone Curing
– Analytical Chemistry Lab
– SolidWorks 3D Modeling
– 3D FDM Prototyping
– Robotics and Automation
– Equipment and Tool design and manufacturing
– Lean Manufacturing and Six Sigma
– Supply Chain Management
– Catheter Design & Construction (Braiding / Coiling, Reflow, Tipping)

Services
- Product Development from Concept to Commercialization
 – Prototype Development
– Feasibility and Bench-top Testing
– Design and Development for Manufacturability
– Design Verification, and Validation Testing
– Process Development and Validation
– Clinical and Regulatory Support
- Commercialization
– Contract Manufacturing
- Manufacturing and Asset Transfer
– Supplier Development.

Quality Management System
Certifications
ISO – 13485:2003 Certified
ISO – 14644-1: Class 7/10,000
Compliance
FDA – 21 CFR Part 820
CMDR – Canadian Medical Device Regulations
MDD – Medical Device Directive 93/42/ECC