OSYPKA AG

Earl-H.-Wood-Str. 1, 79618 Rheinfelden
Germany
Telephone +49 7623 7405-0
Fax +49 7623 7405-160
mail@osypka.de
http://www.osypka.de

Product Categories

Product categories

01 Manufacturing of components
01.02 Plastics processing
01.02.01 Injection molding

Injection molding

01 Manufacturing of components
01.02 Plastics processing
01.02.02 Extrusion

Extrusion

01 Manufacturing of components
01.03 Toolmaking, mold making

Toolmaking, mold making

01 Manufacturing of components
01.06 Laser processing
01.06.01 Laser cutting

Laser cutting

01 Manufacturing of components
01.06 Laser processing
01.06.02 Laser welding

Laser welding

02 Manufacturing of finished products
02.02 Catheters

Catheters

02 Manufacturing of finished products
02.08 Implants (active)
02.08.01 Cardiac pacemakers

Cardiac pacemakers

02 Manufacturing of finished products
02.08 Implants (active)
02.08.04 Neuro-stimulators

Neuro-stimulators

03 Services
03.04 Design and development
03.04.01 Product design, product development

Product design, product development

The complete solution for your customized medical product

03 Services
03.06 Contract packaging

Contract packaging

03 Services
03.08 Sterilization

Sterilization

07 Microtechnology
07.08 Microprocessing
07.08.01 Micromolding

Micromolding
Our products

Product category: Product design, product development
The complete solution for your customized medical product
OSYPKA AG – Your single-source partner for your HIGH-TECH project
OSYPKA’s 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

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

Catheter based devices

High precision multilumen catheters
Multi-contact catheters
Cooled tip catheters
Sensor embedded catheter tips
Digital data transmission
Process development, process validation and design verification

Contract manufacturing

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

Manufacturing of high precision medical components

Swiss machining
Mold making
Injection molding
Laser and resistance welding
Thermoplastic extrusion
Coil winding
Clean room assembly
Metal parts
Laser marking
Hermetic welding and testing
Packaging and labeling services
etc.

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.

Worldwide distribution

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.

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About Us

Company details

About OSYPKA
OSYPKA was founded in 1977 by Prof. Dr.-Ing. Dr.-Ing. E. H. Peter Osypka.
The company is located in Rheinfelden-Herten, in the southwest of Germany, near Basel, Switzerland.
OSYPKA has been producing reliable, high-quality medical devices for over 40 years and offers its innovative solutions and expertise to other medical technology companies.
OSYPKA manufactures products primarily in the field of stimulation, electrophysiology, cardiac surgery and interventional and pediatric cardiology.
OSYPKA AG is in private hands together with the non-profit and benevolent “Peter Osypka Foundation”.

OSYPKA is certified according to DIN EN ISO 13485: 2016

OEM-Services

OSYPKA AG – Your single-source partner for your HIGH-TECH project

Our high level of vertical integration saves costs and speeds time to market. OSYPKA’s 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.

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 – we offer you a complete solution.

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

Company data
Number of employees

100-499
Foundation

1977
Area of business

Components, parts, modules, Original Equipment Manufacturers
Tubings and tubing equipment
Catheters
Manufacturing Services
Packaging and print
Services

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