Our Quality
In the face of increasingly stringent regulatory, normative and customer requirements, our constant concern is and remains:
- Customer satisfaction through the quality of the service provided
- Respect for our delivery deadlines
- Mastering and ensuring the correct functioning of our equipment and production environments
- Maintaining a high level of competence, professionalism and commitment from Bio-Steril's employees and partners.
The following activities fall within the scope of our quality policy:
- Steam sterilisation of medical devices
- Development of steam sterilisation techniques
- Manufacture of liquid medical devices
- Primary packaging of medical devices
- Secondary packaging of medical devices
- Validation of steam sterilisation methods
- Steam decontamination (e.g. laboratory glassware)
- Packaging prior to transport and delivery
- Manufacturing, primary packaging and steam sterilisation of liquid cosmetic products according to the requirements of the current ISO 22716 standard (Good Manufacturing Practices for Cosmetics)
Regulatory Quality
BIO-STERIL assists its customers in the regulatory and quality aspects of compiling their technical documentation in order to obtain CE marking.
Main standards applied:
– EN ISO 13485 latest version: Medical devices
– Quality management systems: Requirements for regulatory purposes
– EN ISO 17665-1 current version: Sterilisation of healthcare products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilisation process for medical devices
– EN ISO 22716 latest version: Cosmetics, Good Manufacturing Practice (GMP)
Main standards applied:
– EN ISO 13485 latest version: Medical devices
– Quality management systems: Requirements for regulatory purposes
– EN ISO 17665-1 current version: Sterilisation of healthcare products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilisation process for medical devices
– EN ISO 22716 latest version: Cosmetics, Good Manufacturing Practice (GMP)
Our certifications
GMED certificate (download document)
BIO-STERIL is certified ISO 13485:2016 by LNE/GMED for the following activities:
- Development, validation, treatment and routine control of a sterilization process by moist heat for medical devices according to ISO 17665-1:2006 standard.
- Secondary packaging of medical devices.
- Primary packaging of medical devices in liquid form, in vials and syringes terminally sterilized.
- Manufacturing of medical devices in liquid form intended to be sterilized.
- Revelation of biological indicators.
ANSM certification
BIO-STERIL is certified by the ANSM (French National Agency for the Safety of Medicines and Health Products) as conforming to the Good Manufacturing Practices for cosmetic products.
ANVISA Certification
BIO-STERIL is certified by ANVISA (French National Agency for the Safety of Medicines and Health Products) in conformity with the Good Manufacturing Practices for Health Products.
