Medical Device Certification
NSAI’s Global Medical Device Certification Services
NSAI offers a full range of services relating to Quality Management System Standards and Certification Services for medical device manufacturers. We pride ourselves on offering the highest level of customer service and support available in the industry. At present NSAI offers a wide range of services, including: 1. Certification as an accredited Certification Body for (EN) ISO 13485:2016 & (EN) ISO 9001:2015 2. Certification under the Medical Device Single Audit Program (MDSAP) as a Recognized Auditing Organisation 3. CE Marking under (EU) MDR 2017/745 as a Notified Body. NSAI is currently undergoing the designation process for (EU) IVDR 2017/746. NSAI is headquartered in Dublin, Ireland and has regional locations in Galway and Limerick. NSAI Inc is a wholly owned subsidiary of NSAI and acts as its certification arm based in the New Hampshire, USA. NSAI Inc offers the full range of medical device certification services referenced above
NSAI UKCA Marking for Medical Devices
NSAI Certification UK, established in 2021 is undergoing the process of becoming a UKAS accredited Certification Body for ISO 13485 and a UK Approved Body under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). Once fully designated, NSAI Certification UK will operate in tandem with NSAI and NSAI Inc to offer a full range of medical device certification services relating to Management System Standards and Certification Services for medical device manufacturers. As NSAI Certification UK progresses through the accreditation and designation process further information will be communicated.
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