MAST Biosurgery USA, Inc. is a privately held, wholly owned subsidiary of MAST Biosurgery AG, Switzerland. MAST Biosurgery USA, Inc. was founded in 2004 in San Diego, California.
“MAST Biosurgery’s main goal is to better the human condition through the highest Quality of its products and excellent Service to its Customers. We are dedicated to achieving our goal by continuously improving our Quality System, committing to compliance with requirements, and maintaining the effectiveness of the Quality System while constantly evaluating our customers’ satisfaction.”
(From MAST Biosurgery USA, Inc. Corporate Quality Policy)
ISO13485:2012 is the International Standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems.
- EC design examination Certificate in accordance with Annex II, excluding Section (4 ) of Directive 93/42/EEC
- Certificate for Quality Assurance EN ISO 13485:2012 & AC:2012
- Certificate of Registration ISO 13485:2003 CMDCAS