Röchling Medical Lancaster

Röchling Medical Lancaster is a vertically integrated contract manufacturer for the medical device and pharmaceutical industries, operating since 1997 from Lancaster, PA. The company specializes in precision plastic and metal processing (including titanium), serving device manufacturers across orthopedics (spinal implants, bone pastes), endoscopy (flexible and rigid hand-held devices), ophthalmology (eye surgery devices), general surgery, diabetic delivery systems, drug delivery systems (pen injectors), diagnostics (in vitro and point-of-care), cardiovascular, dental, and bio-defense applications. Notable product expertise includes sterile bifurcated needles for smallpox/mpox vaccination and allergy testing. Manufacturing capabilities include 14 injection molding machines (20–180 ton capacity), insert molding, micromolding, metal processing, complex device assembly, and contract packaging. The facility operates ISO 14644-1 Class 7 and Class 8 certified cleanrooms compliant with Pharma GMP Class C standards. The company offers end-to-end services: product design and development, tool making and maintenance, automation engineering, assembly and post-processing, packaging development, and sterilization coordination. Röchling Medical Lancaster holds ISO 13485 certification (Medical Devices Quality Management Systems) and is FDA registered. The parent Röchling Group is a global leader in engineered plastics and composites. The company maintains regulatory expertise in Medical Device Regulation (MDR) and compliance with relevant healthcare standards. As a B2B supplier, it serves OEMs requiring cost-effective, scalable manufacturing with simplified supply chains and quality assurance tailored to product-specific regulatory requirements.