Partnerships are essential to building a solid foundation and is at the center of Osypka Medtec’s core business principles. Our team works to build long-term relationships with our clients that go beyond meeting specifications and terms of projects. We work closely with our clients to streamline processes in a successful yet ethical manner that helps reduce cost, optimizes deliverables, and produces a quality product or component for years to come. Careful attention is given to each client by our team from the design phase up to, and including, finished prototypes and manufacturing. Our goal is to develop and build a partnership based on trust while delivering exceptional end results with the latest technological advances in medical manufacturing.
Located in Longmont, Colorado, Osypka Medtec is an Original Equipment Manufacturer (OEM) and is dedicated to working with medical device manufacturers and suppliers to manufacture innovative, quality product solutions or components for companies around the United States. We provide device technology and products using the latest state-of-the-art design and manufacturing to meet the high standards of our customers. Osypka Medtec also is able to produce speciality assemblies, modifications to standard products, and custom fabrication to meet the needs of product specifications. Our team is dedicated to the successful manufacturing process that is analyzed and optimized every step of the way to maximize efficiency and effectiveness. Osypka Medtec is an ISO 13485 and 9001 certified manufacturer capable of manufacturing compliant value-added products and components.
Our parent company, OSYPKA AG, was founded in 1977 by Peter Osypka, Ph.D., who has more than 47 years of experience in the fields of medical technology and electrophysiology. Today OSYPKA has over 100 patents registered worldwide and is located in Rheinfelden-Herten, Germany.
Excellence, Quality, Integrity, Innovation and Accountability are all core values of Osypka Medtec that underpin our business conduct. We believe that when we apply our ethical principles to our business decisions, the Company is positioned for success. Our values guide our actions and in conducting business in a socially responsible and ethical manner, helping to make OSYPKA AG and Osypka Medtec viable and respectable contenders in the medical market. As an employer of choice and as individuals, we respect the law, support universal human rights, protect the environment, achieve operational excellence and benefit the communities where we work.
To earn the continued loyalty of our patients, healthcare professionals, and customers by consistently demonstrating why we are the first choice for quality, service, value and innovation.
Never to compromise integrity or quality on the health and safety of our patients, customers and employees, and to responsibly manage the impact that our business has on the environment.
To deliver the highest quality and performance while building partnerships and maintaining high standards within the industry market. To be a value driven company that leads in the development, production, sale and marketing of devices and services around the world.
And to recognize the diversity and contribution of our employees, and to create a work environment that is challenging and that provides opportunities and support for everyone to develop, learn and succeed.
EtO Sterilization capabilities : Certified, fully automated parametric release procedure with complete adsorption of residual gases which allows for quicker implant after removal from sterilizer due to shorter cycles. Safe for drug coated and treated products, safe for personnel and environment due to low temperature (38°C) sterilization with 6% EtO (Ethylene oxide gas).
Osypka Medtec offers a unique manufacturing capability process that reduces time, cost and errors so our customers meet their high standards with an exceptional end product.
We have a one-team approach with our parent company, Osypka AG, which enables us to leverage their expertise and production capabilities for manufacturing in the United States and abroad.
Osypka Medtec has the experience required to create a customized process adapted to our client’s needs. We take the time to understand the specific needs of our clients and help maximize and streamline the process of implementation.
Osypka Medtec has a solid quality system in place as part of the change control system. We offer comprehensive services that include planning and procurement, incoming inspections, in-process quality inspections, assembly, packaging, sterilization coordination and shipment options. Maintenance of the quality system is comprehensive and ensures that each critical area of focus is optimized in an effort to help mitigate risk levels and ensure quality contract manufacturing.
Osypka Medtec ensures the highest quality suppliers by maintaining an Approved Supplier List (ASL) as part of our quality system. Our staff reviews data and trends that impact availability, quality and on-time delivery of these suppliers for Class 2 and Class 3 device manufacturing of Active Implantable Medical Devices (AIMD) per EEC Directive-MDD 93/42/EEC.
Osypka Medtec offers a Class 10,000 ISO Class 7 Cleanroom for assembly and packaging. Our manufacturing facility includes an ESD program, hermetic sealing, and laser welding process. Laser welding includes a state-of-the-art 4.5 axes CNC Controlled laser welding system with glove box to hermetically seal medical devices.
Internship opportunities are available during the year, both unpaid and paid for students looking to gain additional work experience within the medical industry. We also have job shadowing opportunities to help clarify choice of major, choice of industry or even job positions here at Osypka Medtec. These are short unpaid experiences during breaks in the academic schedules or as time permits for students to promote their professional development plans. Here at Osypka Medtec we are dedicated to helping the community and encourage outreach within our organization. Please email firstname.lastname@example.org to obtain more information.