Product Development and Contract Manufacturing of Class I & II Medical Devices and Personal Care Products

Our FDA QSR, NMPA (formerly CFDA), and ISO 13485 compliance, along with our well-maintained Class 7 & 8 Cleanrooms, and vertically integrated manufacturing capabilities, enable us to work lock-step with our customers to ensure production is flexible, scalable, and yields high performance results.

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Globally Competitive Manufacturing for Healthcare

Through our quality-driven contract manufacturing, we empower OEMs to speed new products to market, and set the pace of healthcare innovation. We specialize in the manufacture of Class I & II medical devices and personal care products. Examples of categories of products manufactured include Oral Care, Drug Delivery, Respiratory, Diagnostics, Light-based Products, and Personal Care products.

Electric Toothbrushes, Electric Flossers, Disposables, Accessories

Infusion Pumps, Drug Delivery Pumps, Pharmaceutical Drug Delivery, E-Vapor Devices

Nebulizers, Ventilators, CPAPs & BiPAPs, Oxygen Concentrators, Anesthesia Equipment, Disposables

Disposables, Testers, Cardiac Monitors, Blood Collection, Accessories

Hair Growth, Hair Removal, Skincare, Environment Control

TENS Units, Skin Beautification, Cellulite Reduction

Within the above categories, we also specialize in product development involving pump and motor development, electronics assembly, and performing tight tolerance injection molding involving highly engineered resins to mold parts that would need to be autoclavable. Such highly engineered resins include Polysulfone, Ultem®, PPSU, and PEEK materials.

Manufacturing support may include finished goods assembly (including packaging), sub-assemblies, or components (i.e. injection molding only) of mechanical and electro-mechanical systems and may also include production of the device-related accessories. Our Class 7 (10K) and Class 8 (100K) Cleanrooms are well-suited to support various production volumes and are scalable. We also offer sterilization options, including EtO and Gamma Ray.

Our comprehensive suite of manufacturing capabilities yields important benefits that medical device OEMs value, such as achieving high production output, reducing lead times, real-time access to production line performance, high touch account support, and supply chain consolidation. This enables our customers to reduce the complexity and size of their supply base.

Providence uniquely combines the above while ensuring complete compliance with the U.S. FDA’s 21 CFR Part 820, ISO 13485, and China’s NMPA (formerly CFDA).

From design to delivery, Providence is ready to take on your next contract manufacturing project.

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Quality at Providence

At Providence, quality is achieved through the processes we put in place, the personnel we hire and retain, and a culture of perseverance that drives us to become an industry-leading, high quality, contract manufacturer.

Quality starts with embracing solid quality management systems (exemplified by our ISO 9001) and a commitment to information security management (exemplified by our ISO 27001). Our current ISO 13485 certification, FDA and NMPA (formerly CFDA) registrations position us as a world-class supplier of medical and personal care products, and since we are also IATF 16949 and VDA 6.4 certified, the global automotive market is also clearly in focus.

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Engineering Expertise

We excel in the development of mechanical and electro-mechanical systems involving plastics, pumps, motors, and electronics. In addition to consideration for Design for Excellence, we are highly experienced in Design for Manufacturing. Our core engineering experience centers around pump and motor development and working with our customers to collaborate on best design for their product application. Designing and Developing products for efficient and consistent manufacturing, cost effectiveness and quality production is our specialty.

Engineering expertise includes the following:

  • Injection Molded Plastics & Rubber Compression Molded Part Expertise

  • Pumps & Motorized System Support

  • Electronics (PCBA) & Software Development

  • Extensive Sub-Assembly & Finished Good Assembly Experience

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