Osypka

OSYPKA specializes in providing industrialization services tailored to our MedTech Partners, specializing in the production of catheter-based and active implant medical products. Our high level of vertical integration provides design & development, contract manufacturing, regulatory, clean room assembly, injection molding, thermoplastic extrusion, laser welding and cutting, CNC machining, hermetic welding and testing and many other services.

OSYPKA is an international company located in three countries; Headquarters in Rheinfelden, Germany near Basel-Switzerland, OSYPKA Medtec in Longmont, Colorado – USA and OSYPKA s.r.o. in Odry – Czech Republic. We are proud of our high-quality manufacturing and worldwide marketing of medical devices in the field of cardiology with a product portfolio for electrophysiology, interventional cardiology, and cardiac surgery. We use our in-house capabilities and services to support our medical device industry partners in the field of cardiology, neurology, orthopedics, and many others. Our high level of vertical integration provides full control over the design and development of tools, production of components, and assembly of medical products in or out of a cleanroom. The integration under-one-roof saves costs and speed time to market. OSYPKA AG was founded in 1977 by Prof. Dr.-Ing. E.h. Peter Osypka. It is privately owned and operated together with the charitable „Peter-Osypka Foundation“.

Contract Development of active medical implants and catheter based products

The perfect partner to transfer your idea first into prototypes to prove full functionality and operating capability and then transfer your design into manufactural medical devices and components.

OSYPKA’s dedicated team provides design and development services, including; process development, process validations, design verifications, and other services, depending on your needs and requests.

Contract Manufacturing of active medical implants and catheter based products

OSYPKA is your high-tech partner for the realization of your medical product. We are capable of the complete design, development, and manufacture of active implants used for Cardiology, Neurology, Orthopaedics, ENT, and more:

• Electrode extensions
• Implantable power drivelines
• Inline adapters
• Implantable high-voltage connectors
• Hermetic implant encapsulation
• Polymer implant encapsulation

Our wide range of catheter-based devices include:

• High-precision multilumen catheters
• Multi-contact catheters
• Cooled tip catheters
• Sensor embedded catheter tips
• Digital data transmission
• Ablation catheters (irrigated/non-irrigated)
• Diagnostic catheters (steerable/fixed curve)
• RF-Generator
• Valvuloplasty balloon catheters
• Retrieval catheters

Contract Sterilization – Ethylene oxide (EtO) sterilization

Our ethylene oxide sterilization service offers a comprehensive and reliable solution for medical device vendors prioritizing patient safety and product quality. With state-of-the-art equipment and deep industry expertise, we provide effective sterilization that meets the unique needs of each client, alongside value-added services like cleaning, packaging development and validation, and final assembly for a seamless end-to-end service.

Contract manufacturer of high precision medical components

If you are looking for a manufacturing company that provides you with high-volume industrial production of your final medical device, sub-assemblies, or components, then Osypka is your single-source partner; you save costs and speed time to market.

High volume industrial production:

• Final medical product
• Medical sub-assemblies
• Medical components

Regulatory affairs and clinical evaluation support

Osypka provides support to its OEM customers in creating technical documentation to get CE and/or FDA approval for medical devices class I – III and AIMDs.

We are ISO 13485:2016 certified and FDA registered and successfully audited by the FDA as a contract sterilizer.

Furthermore, we have a GMP certificate by ANVISA (Brazil), compliant and registered for Japan (JPAL/PMDA) and our QMS is certified for Belarus and Ukraine.