Quality and regulatory
BioSerenity is manufacturer of medical devices
and as such evolves in a strict normative and regulatory framework,
on which the placing on the market of its products depends.
is a technical specification, approved by a certification organism, whose implementation is not mandatory. It attests the compliance of a product/ service / process / system to a set of requirements. Applicable standards to medical devices et particularly to BioSerenity medical devices are the following (non exhaustive list):
- EN ISO 13485: 2016 – Medical devices – Quality management systems – Requirements for regulatory purposes
- EN ISO 14971: 2012 – Medical devices – Application of risk management to medical devices
- EN 60601-1: 2006 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- EN 62304: 2006 – Medical device software – Software life cycle processes
is a written attestation of compliance with specific requirements.
In accordance with the European legislation, any product meeting the definition of medical device must affix the CE marking, certifying compliance with the provisions of European Directive 93/42/EEC, amended by the Directive 2007/47/EC, that will be replaced, by 2020, by the provisions of Regulation (UE) 2017/745.
BioSerenity products bear the CE marking. This certifies the products’ compliance to a set of harmonized with the provisions of European Directive 93/42/ EEC, amended by Directive 2007/47/EC. In order to anticipate its entry into application, BioSerenity has begun a process of compliance with the requirements of the new Regulation 2017/745.
Among other requirements, the manufacturer is required
to have a quality management system by the Directive evaluated
according to the harmonized standard (ISO standard) in force.
ISO 13485: 2016
Bioserenity’s Quality Management System has been assessed for compliance with the harmonized standard ISO 13485: 2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.
MDSAP (Medical Device Single Audit Program) is an international program that assess medical devices manufacturers’ Quality Management System for the following five territories : USA, Canada, Brazil, Australia and Japan. This recent program allows to certify in one single audit, the quality management system of a company with 5 deviations, combining the provisions of ISO 13485: 2016 with the specific requirements of the following 5 countries:
- US Deviations (21 CFR Part 820)
- Canadian Deviations (SOR 98-282)
- Brazilian Deviations (RDC 16/2013)
- Japanese Deviations (MHLW MO169)
- Australian Deviations (Australian Therapeutic Goods Medical Devices Regulations 2002)
Bioserenity has obtained the MDSAP certificates with the 5 deviations in June 2018. The MDSAP certificate aims to optimize and accelerate the registration of Bioserenity products in these five countries.
The medical device Neuronaute has been granted marketing authorization by the FDA (American Competent Authority) according to the 510 (k) “premarket notification” procedure since the end of 2017.
The regulatory compliance, beyond the certification process of certification, is the respect of a set of legislative and regulatory provisions as well as standards and good practices, in order to adapt to all the requirements applicable to a sector (quality, materovigilance, treatment health data). Through its quality management system and Compliance department, BioSerenity ensures compliance with these requirements for the quality, performance and safety of its products and services.
Corporate Social Responsibility (CSR)
Bioserenity has implemented an approach of Corporate Social Responsibility. As such, the Company is committed to respecting high ethical standards in its interactions with its employees, but also with its customers and partners. From corporate governance to quality management, through the well-being of its employees, transparency, the protection of personal data and respect for the environment, Bioserenity envisions its contribution to society in a sustainable approach , respectful of the context in which it evolves, and dedicated to ensure the quality and the safety of its products.