The QC Loop Concept
We provide full support and services for the identification of applicable standards and full compliance with self-defined and regualtory requriements.
We develop customer-tailored process loops for enhanced management controls, efficiency and the generation of required proofs of compliance to be prepared for regulatory challenges.
Implementation of regulatory control concepts are the basis for measurable solutions. We design and implement integrated management systems to control all kind of requirements on quality, environment, and safety due to lean and flexible processes.
7
Quality Control Loop
We focus on cooperative teamwork and hybrid consulting with fading borders between consultancy and practical implementation. Our interim managers are fit for service from day one and manage complex remediation projects as well as the daily business.
General Manager
Medical Engineering, Dipl.-Ing.
- Interim Management, Audits & Inspections, Regualtory Crisis Management
Product Safety Manager
Electrical Engineering, M.Sc.
Risk Management, Verification & Validation
Just Blogging
Using an environmental management system generates significantly added value in case legal applicable safety at work requirements are defined as quality objectives...
Welcome to our new website!
The QC Loop team is creating a new approach on process-oriented control loops to ensure full compliance for medical device...
NEWS
-
Following the first reading vote of the Parliament in April 2014 and a Council's informal position in October 2015, the Council and the Parliament agreed on a final text on 15 June 2016. At this moment in time, work is ongoing to translate the final texts in all the EU official languages and to correct technical inconsistencies. Final formal adoption is expected both on the Council and the Parliament sides during the first semester 2017. - http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_de
European Commission
-
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. - http://www.iso.org/iso/catalogue_detail?csnumber=59752
ISO org
