The complete solution for your customized medical product
OSYPKA AG – Your single-source partner for your HIGH-TECH project
OSYPKAs 40 year experience in the design, development and manufacture of medical devices provides a one stop shop for your custom made high-tech medical components or products. Our high level of vertical integration saves costs and speeds time to market. From design and development, contract manufacturing, manufacturing of high precision medical components, cleaning, packaging and contract sterilization, regulatory approval and clinical studies to worldwide distribution – Osypka offers you a complete solution.
Design and Development
Osypka AG is your perfect partner to transfer your idea first into porotypes to prove full functionality and operating capability 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.
Active implantable medical devices
Implantable power drivelines
Implantable high-voltage connectors
Hermetic implant encapsulation
Polymer implant encapsulation
Catheter based devices
High precision multilumen catheters
Cooled tip catheters
Sensor embedded catheter tips
Digital data transmission
Process development, process validation and design verification
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
Manufacturing of high precision medical components
Laser and resistance welding
Clean room assembly
Hermetic welding and testing
Packaging and labeling services
Cleaning, packaging and contract sterilization
Osypka offers cleaning and packaging validation services, as well as final cleaning and sterile packaging of products prior to sterilization. Also, Osypka can be your contract sterilization partner.
Regulatory approval and clinical studies
Osypka is ISO 13485:2016 certified. In addition, we are FDA registered and successful audited by the FDA as 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.
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.
Osypka provides logistics support to its customers. Our highly integrated system offers warehouse and inventory management under controlled environments, global logistics and supply chain solutions.
Are you looking for an experienced partner for your project who can handle all your needs from quick-turn prototypes to high-volume industrial production?
Then please contact us. We look forward to hearing from you.