CranioWell
  • For Parents
  • For Doctors
  • How it Works
  • Education
  • Results
  • Physicians
  • Partners
Start Now

Quality

Certificates you can open and check.

ISO 13485 for medical-device quality, plus 9001, 14001 and 45001 — issued to CranioWell Medikal at Hacettepe Teknokent, Ankara.

ISO 13485:2016 certificate

ISO 13485:2016

Medical devices — quality management

QMS for the manufacture of orthopedic and related medical products. Certificate no. WRC-CRN-ISO-13485-TR/EN. Valid through 30 September 2026.

Open PDF

ISO 9001:2015 certificate

ISO 9001:2015

Quality management system

Production, import and export of medical, biomedical, orthopedic and surgical materials. CAS no. MS.0750.1488. Valid through 12 September 2026.

Open PDF

ISO 14001:2015 certificate

ISO 14001:2015

Environmental management

Environmental management system for the same medical manufacturing scope. FQC no. 14.24.12158.20498.I. Valid through 29 August 2026.

Open PDF

ISO 45001:2018 certificate

ISO 45001:2018

Occupational health and safety

OH&S management system for medical manufacturing. FQC no. 45.24.12158.30660.I. Valid through 29 August 2026.

Open PDF

CranioWell

  • Home
  • For Parents
  • Find a physician
  • For Doctors
  • Education
  • How it Works
  • Results

The set

  • Baby Ear Shape Corrector Set
  • Molding or otoplasty?
  • Before and after
  • Treatment timeline
  • For clinics

Partnership

  • Distributors
  • Clinician training
  • Start Now

Help

  • Contact us
  • Find a physician
  • Certificates
  • Results
  • Education
  • Parent guide
  • How it Works

Region

  • Türkiye
  • South Korea
  • Azerbaijan
  • Greece
  • Estonia

Certifications

CE · ISO 13485 · ÜTS · EUDAMED

  • Class 1
  • CE
  • ISO 13485
  • ÜTS
  • EUDAMED
View certificates

Baby Ear Shape Corrector Set · Class 1 Medical Device · Used only by physicians. Applied in Türkiye, South Korea, Azerbaijan, Greece, and Estonia. CranioWell Medikal Teknoloji ARGE Sanayi Ticaret Ltd. Şti., Hacettepe Teknokent, Ankara. This site is for information only and is not a basis for diagnosis or home treatment. All rights reserved © 2026.