FDA has published and makes available ALL regulations required for medical device companies. Look them up by searching 21 CFR part 820. And for outside U.S., you can easily obtain ISO 13485 for a ...

What is ISO 13458? This is the easy part; ISO 13485 specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical device ...

Hsinchu, Taiwan, Oct. 25, 2017 – The leading custom ASIC company, Global Unichip Corp. (GUC), today announced the achievement of highly coveted ISO 13485:2016 certification, which make GUC the first ...

IRVINE, CA / ACCESSWIRE / February 16, 2022 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today ...

The new certification is in addition to the ISO 13485 certifications the company has had for engineering since 2009 and manufacturing since 2007 and is a testament to its expertise in developing ...

Abu Dhabi, UAE: ProvenMed announces today that it has received the ISO 13485:2016 certification for Medical Device and Quality Management Systems for its innovative Med-Tech solutions. “We are ...

VANCOUVER, British Columbia--(BUSINESS WIRE)--Excell Battery is pleased to announce that it has received ISO 13485:2016 certification from SGS (www.sgs.com) for the design and manufacture of battery ...

SAN DIEGO, CA--(Marketwire - Mar 7, 2013) - BioLegend in San Diego, CA, a leading provider of antibodies and reagents for biomedical research, has been granted ISO 9001:2008 certification for ...

MILFORD, Mass.--(BUSINESS WIRE)--Boston BioProducts, a longstanding manufacturer of fundamental reagents for the life sciences, today announced that its quality management system (QMS) has achieved ...

SEATTLE--(BUSINESS WIRE)--Kubota Vision Inc. (“Kubota Vision” or the “Company”), a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., ...