Our team will help you develop and manufacture a medical device for maximum commercial market success.

Fitz-Thors provides end-to-end product development and manufacturing services in an FDA-Registered facility for the medical device industry. This includes in-house design, engineering, prototyping, and ISO 13485:2016 certified contract manufacturing. Whether you need a precision medical instrument, device, or complex equipment solution, we offer integrated comprehensive support for your medical project to guide you on a path toward a successful launch and FDA approval.

Fitz-Thors is a contract manufacturer of medical products and components for the medical and life sciences industries. We operate an FDA Registered Facility with ISO 13485:2016 certification through INTERTEK.

We are ISO 13485:2016 certified, offering comprehensive product development and contract manufacturing service provider for the medical products and devices industry. 

  • Multi-Disciplined Manufacturing Process Expertise and Experience

  • ISO-13485 Certified for Medical Device Manufacturing

  • Comprehensive In-House Fabrication and Prototyping Capabilities

  • Established Process to Guide Your Medical Product To Market Launch

Our Process

From device development to contract manufacturing, our team is ready to guide you through the stages to set up a successful path for the commercialization of your medical product. Leverage our broad expertise in manufacturing processes to drive faster production, consistent part quality, and efficiencies in cost.

Services and Capabilities

Areas of Services

  • FDA-Registered Contract Manufacturing Facility

  • ISO 13485:2016 Certified

  • Design Development

  • Prototyping

  • Manufacturing

  • Regulatory / Compliance Expertise

  • Digital Signal Processing (DSP) Programming

Product Design & Development

  • R&D and Proof of Concept

  • Alpha Prototype and Testing

  • Beta Prototype Design

  • Validation and Verification

  • Final Design and Transfer

  • Design History Files

  • Manufacturing

  • Component and Assembly Drawings

  • Bill of Materials (BOM)

  • Sustained Engineering: Post-Market Services Throughout Product Life Cycle

Contract Manufacturing Services

  • Manufacturing Strategy Development

  • Quality Management System Vendor and Supply Chain Approvals

  • Tooling and Fixture Creation

  • Manufacturing Validation

  • Volume Manufacturing

Other Areas of Support

Our knowledge of the medical device approval process allows us to support your medical device development and ensure adherence to important standards, such as: ISO 13485:2016, IS0 14971, and FDA 21 CFR 801 / 820.

Regulatory Approval Guidance

Our team can offer assistance as you navigate the approval process for your medical product.

  • Regulatory Strategy Development

  • Prepare IDE, PMA, 510(K) Documents

  • Regulatory Submission

Quality Management Support

Leverage our experience maintaining Quality Management standards.

  • Design Requirement Development

  • Maintain Design History File

  • Device Master Record (DMR) Documentation

Business Development Support

Let us help you navigate the path to commercializing your medical product.

  • Market Analysis / Product Pricing

  • Reimbursement Strategy

  • Market Entry and Distributions