This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the ...
Introduces early stage audit readiness solutions to streamline ISO 13485 certification for medical device and IVD companies inline with MDR, IVDR and FDA QMSR CHARLOTTE, NC, UNITED STATES, April 29, ...
CorMedix Inc. (“CorMedix”) (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, announced ...
This course covers changes from ISO 13485:2003 to the ISO 13485:2016 standard and their impact on a company’s Quality Management System (QMS). Topics include the Annex SL framework, methods for ...
Quality management system standards are a great tool for organizations wanting to plan an effective and efficient quality management system. ISO 13485, the ISO standard for medical device quality ...
Dual certifications streamline global design transfers and regulatory compliance. TAIPEI, Nov. 21, 2025 /PRNewswire/ -- IEI Integration Corp. ("IEI"), a global provider of medical and industrial ...
CHICAGO--(BUSINESS WIRE)--Surface Solutions Group participated in an independent audit, conducted by DQS, Inc., which concluded on August 8, 2018. It was determined that all the requirements were met ...
BOSTON, MA, August 22, 2013 – (Accesswire) - Solos Endoscopy, Inc. (OTCPink: SNDY) is pleased to announce that TUV SUD America has completed its Stage 2 ISO 13485 Audit with Solos Endoscopy on August ...
BOSTON, Jan. 24, 2013 /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company and TUV SUD America has scheduled its Stage 1 ISO 13485 Audit for February 26, 2013.