About Us
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 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.
OSYPKA AG is certified according to
DIN EN ISO 13485:2016 + AC: 2015
DIN EN ISO 13485:2016 + AC: 2015
Code of Business Conduct
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.
Guiding Principles:
Delivering Excellence
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.
Safety, Health, and Environment
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.
Constant Focus on Quality, Performance, and Efficiency
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.
Developing Employees and Valuing Diversity
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.
Strengths:
- Long-term experience in the clinical field
- High technology standards
- Sales and production network with focus on the current market
- In-house core process (vertical range of manufacturing 95%)
- Wide range of manufacturing capabilities
- Production and packaging availabilities
- Cleanroom class 10,000 / ISO 7
Innovative Solutions for:
- Material Processing
- Device Assembly
- Prototype Development
- Packaging and Private Labeling
- Sterilization
- Engineering
- Semi-Finished Products
- Finished Products
Contract Sterilization Specifications
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).
