ISO 13485 Accredited Quality Management System
Quick Facts
WE KNOW SUPPLY CHAIN, DEVICE MANUFACTURING AND THE ISSUES THAT AFFECT TODAY’S HEALTHCARE PROVIDERS.
Who We Are
Synchronis Medical is a design, development and contract packaging and manufacturing firm located in Ann Arbor, MI. Our ISO 13485 accredited Quality Management System has given customers around the world, the confidence that our goods and services will be done right, with precision and professionalism.
Synchronis Medical has a dedicated kit-packing division, building specialty kits for civilian and military consumption around the world. Manufacturing is done in our class 8 clean room, on a form, fill and sealing machine, with state of the art in-line printing capabilities.
Senior leadership has over 100 years of combined medical device experience, ranging from class 1 products to Premarket Approved Devices. We have patents and IP around products that are utilized by every military on the planet, including the Halo Seal and Halo Vent Chest Seals.
We’ve earned our stellar reputation through hard work, ethical practices, and years of clinical and practical experience, to help our customers solve their product needs.
Synchronis Medical offers a full range of medical kitting in our Class 8 cleanroom with a Form, Fill and Seal machine featuring in-line printing capability for sterile kits. A second production room for lower run, specialty kits and high volume convenience kits needing impulse sealing technology.
ISO 13485 accredited quality management system. Synchronis Medical private labels for some of the largest hospitals systems, IDN’s and medical manufactures around the world. We believe in building your concepts and your brand.
Sourcing Services
We provide custom, product sourcing solutions focused around clinical quality and cost savings, enhancing quality for your healthcare providers.
Personal protective equipment, commonly referred to as “PPE”, is equipment worn to minimize exposure to a variety of hazards. Let Synchronis Medical help you find the correct product to keep your healthcare workers safe.
Sterilization Services
Synchronis Medical has extensive experience guiding projects through the sterilization process. From validation, bio burden monitoring, shelf life and package integrity testing to process controls and record maintenance. Most importantly, Synchronis Medical has extra ETO chamber capacity, available and ready to be used by your company.
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