Quality Management System (QMS) Compliance

Our Quality Management System according to the provisions of the Medical Device Directive MDD 93/42/EEC Annex II (excluding Section 4) under application of article 120: Transitional provisions, Medical Device Regulation (MDR 2017/745) for manufacturers of medical devices in the European economic area. This QM system fulfills the international standard ISO 13485

Regulatory & Certification Status

Note:

  • Outgoing Notified Body: DQS Medizinprodukte GmbH (NB 0297)
    – Issued the MDD EC Certificate and performed conformity assessments.

  • New Notified Body: Kiwa Dare B.V. (NB 1912)
    – MDR application submitted; transfer agreement for legacy device surveillance signed.

The Manufacturer’s Declaration and Notified Body Confirmation Letter confirm the validity of the transitional period and the MDD EC Certificate extension.

Person Responsible for Regulatory Compliance

Information on the responsible person according to Article 15 of Regulation (EU) 2017/745 (MDR)

Single Registration Numbers / SRN numbers:

Actor ID/SRN : DE-MF-000020585 (Role: Manufacturer)
Actor ID/SRN : DE-IM-000044062  (Role: Importer)

Person Responsible for Regulatory Compliance (PRRC):

Name of PRRC:
Johannes Messow (Head of Quality Management & Regulatory Affairs)
Phone: +49 (0) 6151/95147285

Quality Management System Certificate

EN-ISO 13485:2016

EC CERTIFICATE

Annex II – excluding Section 4 of Council Directive 93/42/EEC concerning medical devices

Manufacturer’s Declaration

MDR MedCom signed

Document 2366

Template: BRF_Confirmation letter