Medical Device Qualified Supplier Directory
Röchling Medical Company Profile
A Premier Provider of High-Quality Contract Manufacturing, Development, and Packaging Services
Qualifications: ISO 13485, ISO 9001, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: Worldwide
Röchling Medical is part of the Medical Division within The Röchling Group, an established, global plastics engineering company with over $2 billion in revenue across 93 locations in 26 countries worldwide.
Röchling Medical provides a complete contract manufacturing solution. Our strong up-front in-house engineering allows us to control the process every step of the way. Röchling Medical provides engineering support from design for manufacturability all the way through ongoing manufacturing. Whether it’s product realization, process design and development, or product line transfers, Röchling Medical engineers bring fresh insights and innovative solutions to any project.
One of our core strengths is rapid tooling, which means we can accommodate machine changes quickly and accelerate the early design process. Our on-site tool shop provides accelerated tooling, designed for manufacturability and production. We have 61 presses on-site, ranging from 22 to 550 tons to support your molding needs. Our molding capabilities include two-shot molding; insert molding, unscrewing molding, vertical molding, and automation.
We are comfortable working with metal and plastic components and can offer medical device assembly, medical device component manufacturing, and contract packaging in ISO-certified Class 7 (FS209E Class 10,000) and Class 8 (FS209E Class 100,000) clean room areas. By integrating many technologies under one roof, we simplify your supply chain and become a single-source provider who can handle your metal work, plastic injection molding, device assembly, packaging, and sterilization requirements.
Metalworking— Röchling Medical is known as a premier source for a wide variety of specialty needles and cannula and can incorporate multiple metalworking technologies. We also offer a number of services to add value to our metalworking capabilities — for example, a monitored reverse osmosis water system to meet the washing requirements of metal components and assembled products.
Plastic Injection Molding— Röchling Medical is one of the rare OEMs that offers both metalworking and thermoplastic molding production capabilities. Customers rely on our extensive plastic injection molding operation to manufacture plastic parts on any scale, from micro plastic parts and components to larger-scale medical devices. Our expertise includes cannulas and obturators, laparoscopic vessel sealing devices, IV components, trocar components, catheters, blood analysis devices, and reagent closures.
Device Assembly— Röchling Medical’s facilities include certified ISO Class 7 (FS209E Class 10,000) and ISO Class 8 (FS209E Class 100,000) clean room areas to control bioburden and minimize contamination of products during assembly and packaging. We’ll work closely with your team to determine the appropriate assembly system — manual, semi-automated, or fully automated — based on your budget and volume demands. We have the ability to perform lower-volume hand assembly and testing, but we can also develop and integrate high-volume semi- and fully automated assembly solutions as volumes increase.
Packaging—With six machines onsite, Röchling Medical is uniquely equipped to accommodate diverse packaging needs. Our machines can handle high- and low-volume runs, as well as fill-and-seal and peelable-pouch configurations.
Sterilization— Röchling will work closely with your product team to coordinate the sterilization techniques, including both radiation and ethylene oxide that can be used on products in both pre- and post-assembly environments.
We know it takes a team of dedicated professionals to meet project objectives and quality standards, so we make it easy for teams to communicate, collaborate, and contribute great thinking. As a result, we have a stable and growing workforce that our customers can rely on, regardless of a project’s size or complexity.
Our facilities are certified to the highest standard, including ISO 13485 and ISO 9001. We are also FDA regulated.
Competence in Plastics brochure
Röchling Medical brochure
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For more information contact Röchling Medical
Röchling Medical Lancaster
44 Denver Rd.
T (717) 375-3700