Quality Management

Strategic Pillars of 7s Medical

Four Pillars of 7s Quality Management

Innovation
7s Medical offers a broad portfolio of high-quality products and attractive innovations. Product development is one of 7s Medical’s core competencies and enables improved patient care.

Education
Customers and users benefit from high level trainings with renowned high class faculties.

Dedication
A passionate and experienced team of employees and partners ensures that customers and users are optimally supported.

Quality
A comprehensive system of quality assurance measures ensures that the quality and continuous availability of products can be guaranteed.

Quality - More than the fulfillment of regulatory requirements

The Medical Device Regulation (MDR) will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC) after a transition time of three years on 26.5.2020. For 7s Medical AG, quality means more than just meeting regulatory requirements – the ultimate goal is improved patient care and a continuous supply of high-quality products. For this reason, 7s Medical has massively increased the quality requirements across the entire value chain and implemented a network of measures. The 7s quality management concept consists of the following core areas:
Quality-Management

A – Quality Management System
All our suppliers are ISO 13-4-85 certified and have either CE or FDA certificates. We systematically monitor our suppliers and their quality management systems through experienced auditors. These processes as well as the processes mentioned below are managed and audited within the framework of the 7s quality management system.

B – Interdisciplinary Development and Assessment of Products by Experts
During the development and evaluation of products, a thorough examination and evaluation is carried out by experts with many years of experience in the industry (renowned physicians, engineers
and medical technology experts etc.) with regard to functionality, user-friendliness, quality and safety. These product assessments are interdisciplinary and meet the highest standards due to their integrated approach.

C – Quality Assessments
When selecting suppliers, potential suppliers as well as their quality management systems are examined by a qualified auditor carrying out pre-assessments. Before a supply contract is concluded, a quality assessment is performed on site in order to thoroughly assess product quality, process quality and the quality management system itself.

D – Technical Quality Assurance
To agree specifications (design, raw material, processing, etc.) and production standards, contracts such as the Technical Quality Assurance are signed with the supplier. The Technical Quality Assurance defines, inter alia, the way in which quality controls are carried out and compliance with regulations (batch tracking, storage of production data, etc.) in general.

E – Continuous Observation and Vigilance
All suppliers are systematically monitored by 7s Medical and are audited at least once a year as part of the supplier audits. Besides the permanent post market surveillance and vigilance, the monitoring of the CE certificates and the CE certification processes of the suppliers are also taken seriously. In addition, the status of the Notified Bodies is regularly monitored. Most of the products we currently sell are certified by TÜV, a Notified Body with an excellent image that is regarded as very reliable and promising. The CE certificates are available on request.

Certificate of Compliance

Certificat of Complience