NeoMed is proud to announce that it has successfully completed an MDSAP certification/ISO 13485 recertification/ISO 13485:2016 transition audit, which resulted in recommendation for certification to MDSAP, recertification of ISO 13485, and transition to ISO 13485:2016. The audit took place at NeoMed headquarters in Woodstock, Georgia on Sept. 11, 2018 – Sept. 13, 2018 and concluded with no open findings.
The Medical Device Single Audit Program (MDSAP) is a program that allows for one regulatory audit of a medical device manufacturer’s quality management system (QMS) that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements.
The MDSAP allows medical device manufacturers to be audited once for compliance with ISO 13485:2016 and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan, and the United States. NeoMed currently markets, or intends to market in four of these countries. The program’s main mission is to jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.
“Successfully completing this audit by closing with no open findings and receiving recommendation for certification to MDSAP and recertification of ISO 13485, including transitioning to ISO 13485:2016, is a significant achievement that warrants praise. It offers evidence that our quality management system provides the fundamental foundation needed to ensure we continue to design and manufacture medical devices that consistently meet customer expectations and applicable regulatory requirements. I am very proud of the NeoMed team for this tremendous accomplishment,” said Melinda Smith, Vice President of Quality and Regulatory Affairs.
About NeoMed, Inc.
Founded in 2007, NeoMed develops innovative enteral collection and delivery products supporting the specialized feeding and medication dosing needs of the low birth weight, neonatal, and pediatric patients. With 250 successful ENFit transitions representing over 21 million administered feed and medication doses, NeoMed is committed to improve patient outcomes through product designs that meet safety, clinical, and regulatory guidelines while supporting cost-containment objectives.