ISO 13485 Certified 15+ Years in a Row | World's First & Largest Custom SUT Library
Discover our North American designed and manufactured products.
Experience our Class 7 Clean Room—7 Rooms across 4 locations.
We have Class 7 & 8 molding capabilities.
Explore our cGMP Control for single-use manufacturing.
We celebrate 15 years of ISO 13485.
Discover our North American designed and manufactured products.
Experience our Class 7 Clean Room—7 Rooms across 4 locations.
We have Class 7 & 8 molding capabilities.
Explore our cGMP Control for single-use manufacturing.
We celebrate 15 years of ISO 13485.
Discover our North American designed and manufactured products.
Experience our Class 7 Clean Room—7 Rooms across 4 locations.
We have Class 7 & 8 molding capabilities.
Explore our cGMP Control for single-use manufacturing.
We celebrate 15 years of ISO 13485.
Discover our North American designed and manufactured products.
Experience our Class 7 Clean Room—7 Rooms across 4 locations.
We have Class 7 & 8 molding capabilities.
Explore our cGMP Control for single-use manufacturing.
We celebrate 15 years of ISO 13485.
Discover our North American designed and manufactured products.
Experience our Class 7 Clean Room—7 Rooms across 4 locations.
We have Class 7 & 8 molding capabilities.
Explore our cGMP Control for single-use manufacturing.
We celebrate 15 years of ISO 13485.
Discover our North American designed and manufactured products.
Experience our Class 7 Clean Room—7 Rooms across 4 locations.
We have Class 7 & 8 molding capabilities.
Explore our cGMP Control for single-use manufacturing.
We celebrate 15 years of ISO 13485.
Discover our North American designed and manufactured products.
Experience our Class 7 Clean Room—7 Rooms across 4 locations.
We have Class 7 & 8 molding capabilities.
Explore our cGMP Control for single-use manufacturing.
We celebrate 15 years of ISO 13485.
Discover our North American designed and manufactured products.
Experience our Class 7 Clean Room—7 Rooms across 4 locations.
We have Class 7 & 8 molding capabilities.
Explore our cGMP Control for single-use manufacturing.
We celebrate 15 years of ISO 13485.
Due to the fact that safety and quality are non-negotiable in the medical devices industry, regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.
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