Medical Device Manufacturers
Pathway Medtech Medical Device Contract Manufacturing Firm
8779 Cottonwood Ave #105, Santee, CA 92071, United States
- Founded 2013
- ISO 13485:2016
About Pathway Medtech Medical Device Contract Manufacturing Firm
Pathway Medtech operates from Santee, California. The company was founded in 2013 by a team of experienced medical device engineers who set out to simplify the path from concept to commercialization. The firm provides end-to-end medical device development and contract manufacturing under one roof. Services span design and engineering, regulatory strategy, quality management, verification and validation, and FDA registration support. Manufacturing capabilities include low-cost U.S.-based production, high-precision short-run assembly, and high-volume capacity. The facility is FDA registered and ISO 13485:2016 certified, and runs a cloud-based quality assurance system that manages quality from initial manual through product introduction and ongoing production. Pathway serves medical device innovators across Class I, II, and III devices, from startups to established medtech companies. Its regulatory team has direct experience with investigational device exemptions (IDE), 510(k) submissions, premarket approval (PMA) applications, de novo classifications, humanitarian device exemptions (HDE), and product and packaging validation. The company was created to reduce development risk and give innovators a single responsive partner from idea to market. By integrating design, regulatory strategy, and manufacturing processes, Pathway aims to shorten the FDA approval timeline for its clients.
Manufacturing capabilities
Core processes
Inspection & quality
Assembly & services
Industries served
- Medical Devices
- Medtech
Company details
- Location
- Santee, California
- Founded
- 2013
- Certifications
- ISO 13485:2016
- Listed under
Frequently asked questions
Where is Pathway Medtech Medical Device Contract Manufacturing Firm located?
Pathway Medtech Medical Device Contract Manufacturing Firm is located at 8779 Cottonwood Ave #105, Santee, CA 92071, United States.
What does Pathway Medtech Medical Device Contract Manufacturing Firm do?
Pathway Medtech Medical Device Contract Manufacturing Firm is listed under Medical Device Manufacturers, and its listed capabilities and products include Contract Manufacturing, Product Development, Design & Engineering, Regulatory Strategy, Verification and Validation and FDA Registration Support.
What industries does Pathway Medtech Medical Device Contract Manufacturing Firm serve?
Pathway Medtech Medical Device Contract Manufacturing Firm lists Medical Devices and Medtech among the industries it serves.
What certifications does Pathway Medtech Medical Device Contract Manufacturing Firm have?
Certifications on file for Pathway Medtech Medical Device Contract Manufacturing Firm: ISO 13485:2016.
When was Pathway Medtech Medical Device Contract Manufacturing Firm founded?
Pathway Medtech Medical Device Contract Manufacturing Firm was founded in 2013.
How do I request a quote from Pathway Medtech Medical Device Contract Manufacturing Firm?
Use the Request a quote button on this page to send Pathway Medtech Medical Device Contract Manufacturing Firm your requirements through FirmsLedger, or call (619) 415-0103 and visit pathwaymedtech.com.
What companies are similar to Pathway Medtech Medical Device Contract Manufacturing Firm?
Other Medical Device Manufacturers in California listed on FirmsLedger include Medicatech USA, HDA Technology, Inc. and GE Healthcare.