PSN Manufacturing Achieves Two Quality-Related Certifications

PSN Manufacturing has achieved ISO 9001:2015 and ISO 13485:2016 certifications, a deed the company claims highlights its dedication to quality management and regulatory compliance in the medical device sector.

The ISO 9001:2015 certification confirms PSN Manufacturing’s quality management system across its manufacturing operations, ensuring consistent processes, continuous improvement, and customer satisfaction for manufacturing components and sub-assemblies for various industries (including medical devices).

The ISO 13485:2016 certification specifically validates the company’s quality system for manufacturing medical device components and sub-assemblies.

“It’s amazing to see the growth and quality of our team at PSN Manufacturing, which is cemented by receiving both ISO 9001 and ISO 13485 certifications so early in our journey, as it is a significant milestone that reflects the strong foundation we’ve built,” PSN Manufacturing Quality Manager Matt Heidecker said. “These certifications bring the vision of being a true CDMO across the businesses to reality and reinforce our commitment to delivering precision components and scalable manufacturing solutions to our clients in the medical device, aerospace, oil and gas, and other industries in a way that is emblematic of what our customers actually need.”

PSN Manufacturing operates in close partnership with its sister company, PSN Labs, to deliver a fully integrated contract development and manufacturing organization (CDMO) model, providing end-to-end support from initial concept through commercialization. While PSN Labs leads product discovery, engineering, and development, PSN Manufacturing brings those innovations to life through prototyping, tooling, and scalable production. Ideal for startups as well as medical and non-medical OEMs, this unified approach eliminates traditional gaps between development and manufacturing, reduces risk associated with design transfer, and ensures continuity in quality, communication, and technical expertise—enabling customers to move from idea to market with greater speed, confidence, and efficiency, according to the company.

PSN Manufacturing operates a state-of-the-art, 100% climate-controlled facility that includes a Class 8 cleanroom and a spacious general molding floor. Both areas are designed to accommodate a wide range of injection molding machines from 50T to 500T. The facility also features dedicated warehouse space, a metrology lab, and in-house tooling capabilities for maintenance and repairs. Additional square footage is available to support rapid expansion as capacity needs grow.

PSN Manufacturing offers a range of advanced manufacturing capabilities to support programs from early-stage development through full-scale production, including thermoplastic and liquid silicone rubber (LSR) injection molding, insert and two-shot molding, and prototype molding. The company also provides onsite tooling support for preventative maintenance and repairs, mold transfer support, as well as value-added processes such as extrusion, pad printing, inspection, and metrology. Together, these capabilities are supported by a quality-focused production system designed to ensure repeatability, scalability, and consistency across highly regulated and performance-driven industries.

PSN Manufacturing serves numerous industries, which include medical devices and combination products, pharmaceutical, aerospace, consumer goods, oil and gas, petrochemical, and packaging, among others.

“It is important to note that PSN is not new to manufacturing,” PSN Labs President Mike Alabran stated. “We have long been active in the injection molding environment for new product development or for troubleshooting legacy products for our clients. This next step is simply the natural progression that has come at the request of our existing clients. For decades, we have been developing unique products that have ultimately led to manufactured components, either with our clients directly or at other contract manufacturing facilities. By expanding our operations to include a manufacturing division, we are offering our clients a true one-stop shop experience with a partner that fully understands the development challenges and intricacies unique to their products. This allows us to establish a more robust program while mitigating our clients’ risks at the same time.”

PSN Manufacturing and PSN Labs are sister companies based in Erie, Pa., that together operate as an integrated CDMO to support the full product lifecycle. PSN Labs focuses on engineering, early-stage innovation, and advanced product development, including comprehensive testing services and biocompatibility support. PSN Manufacturing is the manufacturing partner, delivering precision components and sub-assemblies with an emphasis on consistency, quality, and scalable execution. This connected model reduces fragmentation between vendors and improves technical continuity, helping customers move from design to market more efficiently.