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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, approved by a certification body, where its implementation is not mandatory. It attests the compliance of a product/service/process/system to a set of requirements. 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 processes

A CERTIFICATE

is a written attestation of compliance with specific requirements.

REGULATORY COMPLIANCE

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

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 with 2 Juridictions June 2018. The  MDSAP certificate aims to optimize and accelerate the registration of Bioserenity products in these two countries (Canada, USA).

MDSAP Certificate

CE MARKING

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 May 2021, by the provisions of Regulation (EU) 2017/745.

BioSerenity products bear the CE marking. This certifies the products’ compliance to a set of harmonized specifications 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 (EU) 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.

CE Certificate

NEURONAUTE INTENDED USE

The Neuronaute, is a medical device, composed of a garment and an application, recording electrophysiological signals for electroencephalography purposes.

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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.

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Class IIa medical device

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The Neuronaute does not provide a medical diagnosis

Manufactured and distributed by BioSerenity

CE 2797 / Neuronaute cap FDA cleared

 

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.

CARDIOSKIN INTENDED USE

The Cardioskin, is a medical device, composed of a garment and an application, recording electrophysiological signals for electrocardiography purposes.

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Cardioskin is designed to be used by a patient to transmit multiple-lead ECG signal to a physician’s office, hospital or other remote location under medical supervision.

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Cardioskin target population is adults

Class IIa medical device

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The Cardioskin does not provide a medical diagnosis.

Manufactured by BioSerenity and distributed by BioSerenity and We Health by Servier

CE 2797

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.

Last update :19 november 2020

USER GUIDE

Click on the URL Link to have more information about the User guide, notice the BioSerenity Team if you don’t have credentials for the plateforms.

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NeuroNaute : https://neuro-hds.app.bioserenity.com/fr/auth/login

CardioSkin : https://www.cardioskin.com/fr/auth/login 

Emocare : https://www.bioserenity.fr/_files/ugd/5c509b_f2177fd80ee142d688bd88a49c28cad5.pdf

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IFU FFP Mask

IFU Medical Device Mask 

 

(*Information : all mask are complied with the regulations since May 26, 2021, all the product remains the same, for you safety, more information are available on the masks packaging).

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