Award-Winning Medical Device Contract Manufacturing From Pathway Medtech
Pathway Medtech, a leading medical device manufacturer, is proud to announce that it has won the prestigious Core77 Health & Wellness Design Award for its design work on the UpLyft®, the world’s first seated self-transfer system of its kind.
The San Diego-based business also beat out many larger competitors. Pathway Medtech provided extensive design, engineering, regulatory, and manufacturing support for this project. Pathway Medtech also received a notable in the Commercial Equipment category.
What We Offer:
- FDA/ISO Certification
Our FDA/ISO 13485-registered facility is home to an industry-leading quality/regulatory team focused on product excellence and efficient market clearance. - Quality Management
Leverage our audited, cloud-based quality assurance/quality control system to manage growth and expenses. - New Product Development
No design is complete until your product can be manufactured efficiently and repeatedly, and meets all relevant quality standards. - Design & Engineering
Concept development expertise for both functional design and regulatory-focused design. - Regulatory
Develop the right regulatory approach for your product to get to market quickly. - Manufacturing
Low-cost, U.S.-based manufacturing options, high-precision short-run assembly, and high-volume manufacturing capacity.
Get Award-Winning Contract Manufacturing Help for Your Medical Device
California’s Medical Device Experts: Quality Assurance, Development, and Manufacturing
Is your medical device ready for assembly? Pathway Medtech offers scalable, cost-effective contract manufacturing from small to large-volume production (with much less of the hassle interjected by the competition). We can help you meet your production goals without compromising the quality of your product. Change orders, testing, material building, and documentation are all handled and expedited by our experienced professional team with minimal impact on time and budget. It’s our goal to support your business’s entrepreneurial spirit and get your project to the finish line seamlessly and without needless hurdles.
ISO 13485:2016 Certified
ISO 13485 was developed by the International Organization for Standardization (ISO) to create stringent standards for the quality management process—with specifications included for the medical device industry. ISO defines a medical device as “a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.” ISO 13485 certification ensures that medical devices meet rigorous industry requirements for design, production, installation, and servicing.
FDA 21 CFR 820 Quality System Regulations
Pathway Medtech adheres to FDA regulations that address applicability and good manufacturing practices. This oversight ensures that products brought to market with our help are both safe and effective in accordance with the Federal Food, Drug, and Cosmetic Act. We also make certain that products maintain compliance with 21 CFR Part 820, which is part of Current Good Manufacturing Practice (CGMP) regulations.
ISO Class 6/7/8 Clean Rooms
Our clean rooms are maintained in accordance with both industry and international regulatory standards. This controlled environment earns its classification level according to the cleanliness level of the air, with rankings ranging from ISO 1 to ISO 9. ISO classes 6, 7, and 8 are among the most commonly required clean room classifications for medical device manufacturing processes.
Get Award-Winning Contract Manufacturing Help for Your Medical Device