Iso standard 13485

Swiss Bio Inov designs, develops and markets photonic therapy technologies in the medical field. The ATP38® device is ISO 13485 certified and CE marked: see document.: see the document.

Swiss Bio Inov also complies with the electrical safety and electromagnetic compatibility standards (EN60601-1 & EN60601-1-2): see certificate.

"In order to comply with the normative and regulatory requirements, Swiss Bio Inov surrounds itself with professionals from the Medical Devices sector in the field of Quality and Regulatory Affairs".
All products are delivered, referenced and listed in compliance with the standards in force.
The manufacturer reserves the right to make any changes without notice to improve the quality of its products.

Presentation of ISO 13485

ISO 13485 specifies the requirements of quality management systems (QMS) for the medical device industry.
To obtain ISO 13485 certification, Swiss Bio Inov has called upon a "notified body" which has drawn up with it, on the basis of the standard, the procedures to be implemented to guarantee the safety and quality of the products or services that it sells from conception to recycling.
The ISO 13485 certification gives the indication that Swiss Bio Inov follows a procedure recognized by an independent body that audits it regularly. The certification also simplifies the CE marking of products marketed by Swiss Bio Inov.


ISO 13485: 2016 certificate - NF EN ISO 13485: 2016

Different aspects implemented concern:
   - Compliance with regulatory requirements
   - The mastery of special processes
   - Risk analysis throughout product development
   - Clinical trials and long-term follow-up of these trials
   - The organization of materiovigilance
   - Control of the traceability of the configuration of each medical device delivered

 

Materiovigilance

Materiovigilance is intended to monitor incidents that may occur during the use of the Medical Device (MD), the monitoring of incidents or the risk of incidents resulting from the use of medical devices after they have been placed on the market. that is, once these medical devices have passed through the door of health facilities.

Specific procedures must ensure the quality of their supply, storage, commissioning or dispensing, the maintenance of their performance and their level of safety, their prescription and finally the training of those who have to use them.

Materiovigilance is also a way to prevent defects on different medical devices. Indeed, when a defect occurs on a DM, a materiovigilance sheet is then filled out and sent to the qualified person in the hospital (local correspondent of materiovigilance), the ANSM and the DM manufacturer.

CE marking

The CE marking (currently for "compliant with the requirements") was created under European technical harmonization legislation. A product marked "CE" meets certain technical standards and acquires the right of free movement throughout the European Union.

Symbolized by a logo, and sometimes followed by the identification number of a "notified body", it is mandatory for all products covered by one or more European directives that explicitly provide for it. To affix the CE marking to a product, the manufacturer or the importer must carry out, or cause to be carried out, design verifications, or controls, or tests that ensure the conformity of the product with the Essential Health and Safety Requirements (EESS) define in the relevant directive (s).


The fact of affixing the CE marking on a product implies that said product satisfies all the EESSs of the different directives that apply to said material.

QMS

A Quality Management System is the set of guidelines for taking into account and implementing the policy and quality objectives necessary to control and improve the various processes of an organization, which generates the continuous improvement of its results and performances. Quality management is a central area for the company. It is therefore often useful to imagine a structure for this activity that concerns all services (logistics, business intelligence, finance, marketing / sales). However each service has, a priori, the complete responsibility for its quality.

Quality management is therefore a support activity seeking to give services the capacity to standardize, pool and re-use the resources needed to ensure synergies (or flexibility) and efficiency to achieve the expected business strategy. The implementation of the quality management system is therefore the process supporting the quality of the company.

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Distributor

Swiss Bio Inov Europe

305 Allées de craponne 

13300 Salon-de-Provence - FRANCE

Tél :  +33 (0)4 13 22 83 32

E-mail : info@swissbioinov-europe.com

Manufacturer

Swiss Bio Inov S.A.

Route de Sommentier 14C 

1687 Vuisternens-devant-Romont - SUISSE

Tél :  0041 79 715 14 50 

E-mail : atp38sbi@gmail.com

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Version 1.0.0  Date of update: May 2018
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Manufactured by: Swiss Bio Inov