Thomas Medical has been supporting its customers with medical device concept designs to full scale, finished medical device manufacturing for over twenty years. By facilitating each step in the OEM and private label product development and delivery process, Thomas Medical can get products to the market swiftly. Thomas Medical boasts experienced personnel in each of the following functional areas of expertise:

• Vascular access and catheter delivery experts
• Product development from concept design to regulatory approval
• Project engineer & multidisciplinary engineering team drive each project
• Standard design verification & validation (V&V) activities
• Solid modeling & rapid prototyping to satisfy product feasibility studies
• Collaborative & flexible design process to ensure customers get what they want when they want it
• Design-for-manufacturability approach applied to every project
• On-site custom machinery & fixture design & fab for quick turn-around
• Pre-clinical and clinical evaluation services

• FDA-registered medical device manufacturer, EN ISO:13485 and CAN/ CSA 13485 (Canada) registered
• ISO Class 8 certified clean rooms
• Experienced medical device manufacturing engineering team
• Private label manufacturing of proprietary devices for specific customers
• Strong Lean Six Sigma culture
• Finished product manufacturing and assembly
• Bulk non-sterile product manufacturing and assembly
• 3 shifts operating 5 days per week

• IDE, PMA, 510(k), CE Mark and other regulatory submissions and corresponding submissions maintenance services
• Existing design dossier an technical files on many proprietary devices
• Quality Assurance systems and personnel to support reliable and fast regulatory reporting and follow up

• Dedicated Customer Account Representatives for customer support and account maintenance
• Facilitate and manage unique customer inquiries and requests