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

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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.

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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.