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NeoMed Completes MDSAP Certification and ISO 13485:2016 Upgrade Audit with No Open Findings

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.