Quality

PRODUCT QUALITY IN TERMS OF SAFETY, CONSTANCY AND RELIABILITY

1. Know-how and ongoing product monitoring:

• Risk management from initial product development to the post-market stage

• Technical files, TRACE ONE product specifications

• Ongoing monitoring:- Testing, expert evaluations

  – Quality control and analytical testing

  – Audits (Compliance with standards, regulatory requirements, customer demands)

2. Ongoing monitoring of regulatory developments:

• CE marking files for medical devices, cosmetics files, other technical files…

• Registration, certification – Notified Bodies and competent authorities

• Regulatory intelligence:- Regulations and standards currently in force at French, European Union and international level (Directive 93/42/EEC concerning Medical Devices, the REACH European Union Regulation, EU Cosmetics regulations…)

  – The monitoring of related publications and articles, keeping abreast of developments in relevant not-for-profit bodies and organizations…

Safeguarding the health and well-being of consumers by monitoring compliance with all relevant legal and regulatory provisions.

3. A corporate structure and infrastructure that’s tailored to our customers’ needs:

• Internal and external quality audits and corporate social responsibility audits

• Production sites that are fully compliant with the relevant applicable quality standards and regulations (GMP, ISO…)

• Post-market surveillance and vigilance (for medical devices and cosmetics)

• Crisis management