Regulatory Consulting Services for Medical Devices

CE Marking

Consulting services related to CE marking requirements
Consulting services related to conducting clinical evaluations
Consulting services related to the creation of Technical Files/Design Dossiers
Consulting services related to establishing and operating a QMS that complies with EN ISO 13485
Consulting services related to selecting a European Authorized Representative
Consulting services related to conducting post-marketing safety management activities
Consulting services related to developing quasi-medical devices

Contact Us

SunFlare Co., Ltd. Tokyo Head Office:
  1. Tel: +81-3-3355-1383
  2. Mail: info@sunflare.co.jp
  3. Contact :Shinya Arikawa