This webinar walks you through key milestones as your company prepares for the IVDR date of application in May 2022!
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WEBINAR: PRODUCT INFORMATION FILE
In this webinar we will provide you with an overview about the definition of product information file and also the elements that must include
Legacy Devices and Certificates: Updates from BSI
The BSI announced in June of 2021 updates concerning certificates issued for medical devices. Do you want to know how these changes will affect manufacturers and their industries? Visit Our Website.
French CA issues procedure deal with risks of rupture of essential medical devices and IVDs.
The French CA together with the ANSM has published a management procedure to support the market operators and prevent a shortage of medical devices and in- vitro diagnostic devices.
IFRA Standards – 50th Amendment
The 50th amendment to the IFRA standard prohibits the use of one new fragrance ingredient. Discover more details in our article!
Person Responsible for Regulatory Compliance (PRRC) Seminars (MDR/IVDR)
Two-day seminar delivered by top industry experts! Aimed at providing basic knowledge and concepts to those who are interested in the role of Person Responsible for Regulatory Compliance (PRRC).
WEBINAR: EU- SWISS MRA LATEST
Medical device trade is affected by MDR and lack of MRA update. Find out all the details!
Regulation on General Product Safety: towards stronger consumer product safety
On June 30, 2021, the European Commission published a Proposal for the General Product Safety Regulation. For more details visit our page!
Italian authorities confirm: Air purifiers are not medical devices
The Italian Ministry of Health clarified the proper classification of air purifiers and air decontamination systems, as well as their intended use. Find out all the details here!
New Spanish cosmetic guidance: microbiologically safe cosmetic products
The AEMPS in collaboration with STANPA published a new guide to assist in formulating and manufacturing safe raw materials and cosmetic products. More information can be found here!