ISO 13485 Certification MD 751913 — BSI Audited

The certificate

Shenzhen Dorteam Technology Co., Ltd. operates a Quality Management System which complies with the requirements of ISO 13485:2016 — and the QMS scope is medical devices.

Certificate number: MD 751913
Issued by: BSI (a leading EU notified body and UK approved body)
Verifiable: search the certificate number MD 751913 or the company name "DORTEAM" on BSI's website

We are one of the few companies in the electronic cigarette industry that has obtained ISO 13485 certification while integrating the research, development, production and manufacturing of electronic cigarettes.

What ISO 13485 is

Medical device manufacturing is one of the most regulated sectors there is. The regulatory requirements are intended to ensure manufacturers consistently design, produce and place on the market devices that are safe and fit for their intended purpose — and ISO 13485 is the QMS standard written to meet those requirements.

It is a stand-alone standard derived from the ISO 9000 series, adapted for a regulated manufacturing environment: while it uses the same Plan-Do-Check-Act process model, it is more prescriptive and demands a more thoroughly documented QMS, written to support manufacturers in establishing and maintaining process effectiveness across the full life cycle — design, development, production, installation, delivery through to disposal.

Why it matters for a vape buyer

ISO 13485 is the QMS standard accepted as the basis for CE marking of medical devices under European directives and regulations, and UKCA marking under the UK MDR 2002. A vaporizer factory running its day-to-day production under that standard is operating with the documentation discipline, traceability and corrective-action rigor of a medical-device plant — a meaningfully higher bar than the ISO 9001 certificate most competitors hold.

For buyers, the practical translation: batch traceability, inspection records and documented corrective action are how this factory runs by default, not a special request. See certifications or ask sales for the documentation package.