Solutions Matter can assist with the development of medical devices anywhere along the project timeline. Solutions Matter’s breadth of experience and flexibility supports small and large companies to achieve their goals in a cost efficient, timely manner.

Strategic Business Development

  • Develop concise project schedule with defined deliverables and dates
  • Responsible for ensuring all suppliers are approved as required by regulatory agencies and ensuring appropriate quality agreements are in place.
  • Conducting post-sterilization verification and validation testing. 
  • Access to network of Contractors/Distributors/Manufacturers with Expertise in Medical Device Development

Intellectual Property

Solution Matter and its contacts provide cost effective strategic intellectual property development.

  • US Patents
  • PCT

Device Design and Specification Provider

  • Creating a concept or an idea for a new device.
  • Building Proof of Concept design and documentation
  • Developing design specifications, drawings, manufacturing process instructions and training technicians
  • Process Development and COG’s Reduction
  • Equipment Specification & Installation

Prototyping

  • R&D 
  • Manufacturing 
  • Mechanical test labs
  • Testing stations & laboratories
  • Distribution

Quality System Design and Management / Regulatory Strategy

  • Development of Quality System for Medical Device Production 
  • Design Control 
  • Risk Management
  • Quality Assurance 
  • Supplier Quality 
  • Post Market Surveillance 
  • Auditing, Audit Preparation and Management
  • Inspection Readiness & Response Management

Regulatory

  • 510k
  • CE Mark
  • PMA 
  • Clinical Studies

Develop and Complete Testing Required for US and OUS Regulatory Submissions

  • Biocompatibility Testing
  • Transit Testing
  • Shelf Life Testing
  • Verification and Validation Testing
  • Usability Testing
  • Pre-Clinical Animal Studies

Automation and Manufacturing Scaleup

  • Medical Device Assembly Fixturing
  • Balloon Blowing
  • Lamination
  • Steerable Catheter Fixturing
  • Catheter Tipping
  • 3D Pinting