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 Senior QA manager 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.

BSI Assurance Mark

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