Tuttnauer T-Edge - Applicable Regulation and Quality Standards

1.2 Applicable Regulation and Quality Standards
The life cycle of Tuttnauer's T- Edge 11 is in compliance with the following
regulation and quality standards:
Medical Device Directive 93/42/EEC as amended by 2007/47/EC
Medical Device Single Audit
Program
companion document, doc# MDSAP AU
G0002.1.004 rev. 13-04-2017Ft
MDSAP audit approach doc# MDSAP AU P0002.005
FDA QSR 21 CFR part 820 & part 11
Australian Therapeutic Goods (Medical Devices) Regulations 2002
Brazilian Good Manufacturing
Practices
(RDC ANVISA 16/2013, 67/2009,
56/2001, 23/2012)
Japanese QMS Ordinance (MHLW MO 169)
Canadian MDR (CMDR) SOR/98-282 (2018), consolidated
Global Unique Device
Identification Database (GUDID)
Guidance for Industry and Food and Drug
Administration Staff
ISO 9001: Quality Management System
EN ISO 13485:
Quality Management System – Medical
Devices
ISO 14001: Environmental management system
ISO 17025:
General requirements for the competence
of testing and calibration laboratories
EN ISO 14971:
Medical devices – Application of risk
management for medical devices
Page 2