Quality and Regulatory
BioSerenity is a manufacturer of medical devices and operates in a strict normative and regulatory framework that ethically guides the marketing of our devices.
A standard is a technical specification, developed by a consensus of professionals and whose application is verified by. It attests the compliance of a product/service/process/system to a set of requirements. The main applicable standards to medical devices and 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: 2019 – 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 process
The regulatory compliance, beyond the certification process, is the adherence to 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, materiovigilence, 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.
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 certification in one single audit, the quality management system of a company with 5 juridictions, combining the provisions of ISO 13485: 2016 with the specific requirements of the following 5 countries:
• US Juridictions (21 CFR Part 820)
• Canadian Juridictions (SOR 98-282)
• Brazilian Juridictions (RDC 16/2013)
• Japanese Juridictions (MHLW MO169)
• Australian Juridictions (Australian Therapeutic Goods Medical Devices Regulations 2002)
BioSerenity has obtained MDSAP certificates since June 2018. The MDSAP certificate aims to optimize and accelerate the registration of Bioserenity products in two countries (Canada, USA).
Neuronaute Intended Use
The Neuronaute, is a medical device, composed of a garment and an application, recording electrophysiological signals for electroencephalography purposes.
The Neuronaute requires operation by a trained healthcare professional.
The Neuronaute only acquires and displays physiological signals, no claims may be made for the analysis of the acquired signals with respect to accuracy, precision and reliability.
The Neuronaute is a Class II medical device according to the classification regulation of the FDA. The Neuronaute does not provide a medical diagnosis
Manufactured and distributed by BioSerenity
Neuronaute with IceCap 2 and 2 Small (K223644)
The operator should always refer to the operating instructions before using the medical device and should carefully read all instructions to ensure its proper use.
Click on the below to have more information about the User Guide, contact the BioSerenity team if you don’t have credentials for the platforms.