ISO Certification

Quality Control and ISO Certification

HealthLink is 100% dedicated to the medical device industry. Our dedicated warehouse locations in the USA and the Netherlands are audited and certified on a yearly basis by the BSI. Our ERP system, Exact Globe, is validated according to FDA: CFR 21 part 11.

HealthLink’s Quality Assurance team is led by our Manager Quality & Regulatory, who is RA certified, PhD and MsC. The QA team leads quality awareness programs, under the umbrella of the ISO13485 certificate.

You can find our ISO 13485 certificate here.