USA
At OSYPKA Medtec, we're thrilled to be your premier Original Equipment Manufacturer (OEM), where innovation meets excellence in the medical device industry. We specialize in partnering with manufacturers and suppliers across the U.S. to bring to life groundbreaking product solutions and components that stand out for their quality and ingenuity. Our facilities encompass a generous 26600ft2 / 2475m² of floor space and are expanding everyday. We are proud to feature Class 7 clean rooms, which equips us with an extensive array of manufacturing capabilities, all adhering to the pinnacle of technological excellence. Our manufacturing prowess is further enhanced by an ESD program, precision hermetic sealing, and cutting-edge laser welding processes.
Embracing a unified one-team approach with our parent company, Osypka AG, we're able to tap into an incredible pool of expertise, vertical integration and production capacity. This synergy allows us to amplify our manufacturing prowess both domestically and internationally, bringing our A-game to every project we touch. Our seasoned experience shines through in our ability to develop processes that are perfectly tailored to meet the unique demands of our clients with the level of documentation needed for Class 3 Active Implantable products. We're dedicated to diving deep into understanding your specific needs, ensuring that we maximize efficiency and smooth out the implementation process for you.
Building Partnerships That Excite
Our commitment to each client is unwavering, with our team by your side from the design stage right through to the creation of finished prototypes and final manufacturing. We're all about nurturing long-term connections that eclipse basic compliance with project specifications. Our ambition is to forge partnerships rooted in trust and to thrill you with exceptional outcomes, leveraging the most advanced technology in medical manufacturing.
Customer Services That Overachieves
Get ready to be wowed by our comprehensive suite of services designed with your success in mind:
- Strategic Supply Chain Management
- Process Validation and Verification
- Inventory Management
- Expert Device Assembly
- Terminal Sterile Packaging
- Sterilization Management
- Distribution
- Precision Glove Box Laser Welding
- Vacuum Drying and sealing
- Individuelle Overmolding Spritzgussverfahren mit Epoxid und Silikon
- State-of-the-Art Silicone Injection Molding
- Detailed Micro-component Machining
- Comprehensive Electro-Mechanical Assembly
- Mechanical Crimping
- Sterline blister and pouch sealing in sterile packaging
- Tension and Compression Testing
- Soldering Techniques
- UV Adhesive Bonding
- Thorough Incoming Inspections
- Thermal Transfer Product Labeling
- Finished Goods Management
A Quality System That Inspires Confidence
We pride ourselves on our robust quality system, a cornerstone of our change control strategy, encompassing everything from strategic planning and procurement to meticulous inspections and quality checks at every stage. Our quality system is meticulously maintained to optimize each critical focus area, minimizing risks, and assuring top-tier contract manufacturing.
We're passionate about ensuring the highest caliber suppliers, which is why we maintain an Approved Supplier List (ASL) as part of our unwavering commitment to quality. Our team actively reviews and responds to data and trends affecting the availability, quality, and punctual delivery of these suppliers, particularly for Class 2 and Class 3 device manufacturing of Active Implantable Medical Devices (AIMD) in compliance with EEC Directive-MDD 93/42/EEC.
Join us in our excitement as we continue to lead the charge in innovation, quality, and partnership in the medical device manufacturing industry!
Member of Board
Vacancies
As part of our team, you will have the opportunity to work on cutting-edge technologies and contribute to the development of life-enhancing medical devices. If you are looking for a rewarding career that allows you to make a meaningful impact, we invite you to explore our current job openings and consider being a part of our mission to advance healthcare through excellence in engineering and manufacturing.