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LNE newsletter : Healthcare sector

First page of LNE newsletter

>> N°10 - Octobre, 2016

>> Evolution in 2016 of the ISO 13485 certification standard relating to quality management systems of medical devices
The latest revised version of ISO 13485 was published on 1 March 2016. Most of its chapters have been modified. Companies should therefore proceed to a careful analysis thereof to upgrade their quality management system in a comprehensive way. The two most important changes are the integration of the regulatory requirements within the QMS and the integration of risk management.

>> Medical Device Single Audit Program: goal for 2019
MDSAP, an international evaluation program for quality management systems dedicated to manufacturers who market their products in Australia, Brazil, Canada, the United-States and Japan, enters a critical phase of its implementation. Indeed, from January 2019, to obtain and maintain any certifying licence for the marketing of medical devices in Canada, a certificate of compliance with ISO13485 in the framework of MDSAP will be required of the manufacturers. It is therefore important to be aware of the MDSAP's application terms and principles.

>> Developing the right MRI safety assessment strategy: a major challenge for manufacturers of medical devices
Medical devices manufacturers are regularly asked about the safety of their products when introduced into an MRI scanner (Magnetic Resonance Imaging). This is the subject of a regulatory strengthening. The placing on the market of an implantable device is now impossible in some countries without prior information on the product safety during an MRI exam. Therefore it becomes a major issue for MD manufacturers, especially with regard to implantable MD.


>> N°9 - June, 2015

>> N°8 - December, 2014

>> N°7 - July, 2014

>> N°6 - February, 2014

LNE newsletter : Cosmetic sector

First page of LNE newsletter

>> N°1 - October, 2016

>> Regulatory changes in the cosmetics industry
The cosmetic products'marketing conditions have recently become more complex in Europe. In order to avoid legal proceedings which may prove to be serious, a special attention must be paid to regulatory requirements, especially during the completion of the product's information package.

>> Container-content interactions in cosmetics: modelling of substance transfers, in order to assess the sanitary safety of packaging
According to Regulation (EC) No 1223/2009, cosmetic products must not endanger human health under normal conditions of use, while the person responsible for the finished product must provide evidence of compliance with this requirement, and finally, the unintentional presence of prohibited substances -including those which migrate from the packaging- must be assessed.

>> Nanomaterials in the cosmetics industry: new characterization needs
The increasing use of nanomaterials during the formulation of cosmetics, confronts the key players of this industry with three major issues (risk assessment, integration in an industrial process, specific regulatory requirements) to which measurement matters are proving to be crucial.

>> Photonics and cosmetic products appearance: the advantages of spectrophotometry
In the field of cosmetics, photonics may be used for studying light, material properties, or even the visual perception of products as a whole (container - content - packaging).


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