Search Results for: medical device

Independent termination as Notified Body for MDR (Medical Device Regulation EU 2017/745) per 31st of October 2019

On behalf of the European Commission, Notified Bodies for medical devices are subject to Joint Assessments with the aim of verifying the competence of Notified Bodies in accordance with the current Medical Device Regulation MDR 2017/745. QS ZÜRICH AG has applied to the EU for the MDR. In December 2018, QS ZÜRICH AG carried out a Joint Assessment with Swissmedic and the European Commission regarding the new MDR (Medical Device Regulation EU 2017/745).

The deviations resulting from the Joint Assessment should be rectified. Unfortunately, QS ZÜRICH AG was forced to conclude that it was only possible to handle the deviations with a disproportionately high effort.

The management has therefore decided to abandon the candidacy as Notified Body of the European Union according to MDR EU 2017/745. QS ZÜRICH AG will therefore cease its activities as a Notified Body in this area of
31 October 2019. Customers were informed of this in June 2019.

The certification according to ISO 13485 quality management without product is not affected by this decision.

 

ISO 13485 – Quality management system for medical devices

Are you a supplier to medical device manufacturers?
Do your customers demand the ISO 13485 quality standard?
Then you should deal with the implementation of this standard. The requirements of ISO 13485 are relevant for suppliers who supply medical device manufacturers with products or services. Through the application of ISO 13485, organizations are able to demonstrate their compliance with regulatory requirements, manage risks and ensure best practice to promote quality and safety and improve processes.

Interested in gaining certification?
Do not hesitate to arrange a meeting with us. On the basis of your information as communicated to us in strict confidence, we will draw up a personalised, clearly formulated offer for you. We offer our services worldwide with the exception of USA and Canada.

We certify

accredited standards

ISO 9001
ISO 14001
ISO 22000
ISO 45001
ISO 3834
ISO 50001
ISO 13485

not accredited

ISO/IEC 22716
The international standard ISO 22716 Cosmetics – Good manufacturing practice (GMP) – Guide to good manufacturing practice ISO/IEC 22716 specifies the requirements for good manufacturing practice for cosmetic products. It was developed for use in the cosmetics industry and addresses the special features of this sector.
Codex Alimentarius
(CAC/RCP 1-1969) Guideline on principles of food hygiene, HACCP
HACCP
Hazard Analysis and Critical Control Points
EU 2015/C95/01
Guideline on principles of Good Distribution Practice of active substances for medicinal products for human use
ISO/TS 22002-4
Specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRPs), to assist in controlling food safety hazards in the manufacture of food packaging
ISO 22301
Standard for business continuity management

private Label
Management system/auditing according your specific sector
QM Fromarte
Quality management system from the swiss umbrella association of
swiss cheese specialists
Qualivista
Quality manual for retirement and nursing homes
SODK Ost+
Swiss quality guideline for institutions for invalid people
Quality standard Canton Aargau
Quality management system in accordance with the Department of Education, Culture and Sport, Division of Special Education, Homes and Workshops, Quality and Supervision Concept