Quality Europe
Quality and regulatory compliance, known as “compliance”, beyond the certification process, means compliance with a set of legislative and regulatory provisions as well as norms, standards and best practices, in order to adapt to all requirements applicable to a sector (quality, materiovigilance, processing of health data).
Through its quality management system and its Compliance departments (Regulatory and Legal Quality), BioSerenity ensures compliance with these requirements in order to guarantee the quality, performance and safety of its products and services in Europe and North America.
GENERAL CONDITIONS OF USE OF THE SITE AND SERVICES OFFERED
Use of the www.bioserenity.com site implies full acceptance of the general conditions of use described below. These conditions of use may be modified or supplemented at any time, users of the site www.bioserenity.com are therefore invited to consult them on a regular basis.
This site is normally accessible to users at any time. An interruption due to technical maintenance may however be decided by BioSerenity, which will then endeavor to communicate to users before the dates and times of the intervention.
The www.bioserenity.com site is updated regularly by BioSerenity. In the same way, the legal notices can be modified at any time: they nevertheless impose themselves on the user who is invited to refer to them as often as possible in order to become acquainted with them.
IN EUROPE: CE MARKING
In accordance with European legislation, any product meeting the definition of Medical Device must be affixed with the CE Marking, attesting to compliance with the provisions of Regulation (EU) 2017/745 applied to medical devices.
BioSerenity products have obtained CE marking. The CE marking notably makes it possible to certify the compliance of BioSerenity products with a set of standards harmonized with the provisions of the medical device regulation.
MDR certificate (BSI notified body)
Among other requirements, the European Regulation requires the manufacturer to have a quality management system assessed according to the harmonized standard (ISO standard) in force.
BioSerenity’s Quality Management System has thus been assessed for compliance with the harmonized standard ISO 13485: 2016 – Medical devices – Quality management systems – Requirements for regulatory purposes.
IN THE USA: CLEARANCE
In accordance with US legislation, any product meeting the definition of Medical Device (unless exempt) must obtain a FDA clearance, attesting to compliance with Title 21 of the US Code of Federal Regulations. This clearance is issued by the FDA (Food and Drug Administration).
Among other requirements, 21 CFR Part 820 recommends that the manufacturer have a quality management system assessed according to the MDSAP program.
The MDSAP (Medical Device Single Audit Program) is an international program for evaluating the Quality Management Systems of medical device manufacturers covering the following territories: United States, Canada, Brazil, Australia and Japan. This program makes it possible to certify in a single audit, the quality management system of a company. Thus, Bioserenity combines the provisions of ISO 13485: 2016 with the specific requirements of the following countries:
US Jurisdictions (21 CFR Part 820)
Canadian Courts (SOR 98-282)
BioSerenity MDSAP has been audited every year since June 2018. The MDSAP certificate is intended to optimize and accelerate the registration of BioSerenity products in these countries.
INTENDED USE BY THE NEURONAUTE
The Neuronaute records electrophysiology signals in real time for the diagnosis of neurological disorders. The Neuronaute must be handled by a health professional trained in its use. The Neuronaute records physiological signals, no claim can be made concerning the analysis of said signals. The Neuronaute is a class IIa medical device and has CE 2797 marking issued by the BSI. The operator must always refer to the operating instructions before using the medical device and read the instructions for use to ensure proper use.
CARDIOSKIN INTENDED USE
The Cardioskin is a medical device composed of a textile and an application, allowing the recording of electrophysiological signals. The Cardioskin is a portable wireless medical device. It allows the acquisition, recording, storage, transmission and display of a 15-lead electrocardiogram (ECG) for the analysis of possible cardiac pathological abnormalities. The Cardioskin is designed to be used by a patient and transmit an ECG to his doctor, hospital or liberal, or on an outpatient basis. The Cardioskin is a medical device for adults. The Carsioskin is a class IIa medical device and has CE 2797 marking issued by the BSI. The operator must always refer to the operating instructions before using the medical device and read the instructions for use to ensure proper use.
A STANDARD
Is a technical specification, approved by a certifying body, the application of which is not mandatory, making it possible to certify the conformity of a product / service / process / system with a set of requirements. The standards applicable to the field of medical devices are specific to each product, for more information consult the declarations of EU conformity below:
Range Neuronaute
* Neuronaute® Head module, Neuronaute® PLUS Core Module & Neuronaute® mobile app (iOS et Android)
Range IceCap
Range Cardioskin
* Cardioskin® Recorder & Cardioskin® mobile app (iOS and Android)
Range BioSerenity Cloud / Plateforme
INSTRUCTIONS FOR USE OF MEDICAL DEVICES
* NeuroNaute: https://neuro-hds.app.bioserenity.com/fr/auth/login