Regulations & Quality

ISO 13485 certified since 2005

The main mission of the “Quality Assurance and Regulatory Affairs” department is to guarantee an optimum quality of service to our customers.

It is based on the quality policy of The Surgical Company fr and on a management system certified by the 2016 version of the ISO 13485 standard.

The Surgical Company fr Quality Assurance and Regulatory Affairs department in numbers :

2 team members to serve you
ISO 13485 certified since 2005
20 training session for new employees
20 tons for 5,500 devices declared as WEEE

It sets up, coordinates, and ensures the monitoring of efficient operating processes as well as the regulatory and legal compliance of the company’s activities.

This includes responsibilities in terms of Health and Safety as well as the Environment :

Regulatory obligations (checks, maintenance, training, etc.)
Elimination of dangerous situations in collaboration with the CSE
Declaration of WEEE (Waste Electrical and Electronic Equipment)

It has also initiated a process to implement the ISO 26000 standard (Corporate Social Responsibility) within The Surgical Company fr by 2021.

Our entire team is at your disposal and is committed to mobilizing all its skills to meet your demands.

You can reach our communication team weekdays from 9AM to 12PM and from 2PM to 4:30PM (4PM on Friday) at 03 89 06 14 44 or by e-mail at the following address : materiovigilances.fr@tscfrance.com