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New risks arising from risk control measures are new risks, so they need to be treated separately. Also, this has nothing to do with a risk matrix. ------------------------------ Marcelo Antunes Regulatory Strategy Consultant, HAS (Harmonised Standards) Consultant for the European Commission Jundiai ...

Olá Marcos, o link está funcionando para mim. Tente buscar no Google por "Should The EU Establish A Central Accountable Managing Structure For Medical Devices?" que ele vai te levar diretamente ao artigo. ------------------------------ Marcelo Antunes Regulatory Strategy Consultant, HAS (Harmonised ...

Hi Erik, I will join online only this time, maybe in the next meeting I will go in person. ------------------------------ Marcelo Antunes Regulatory Strategy Consultant, HAS (Harmonised Standards) Consultant for the European Commission Jundiai Brazil ------------------------------

Conforme colocado pelo @Ryan Connors (em inglês), aqui estão três dicas sobre como usar nosso LNG! 1 - Apresente-se! Conheça seus colegas reguladores contando-lhes um pouco mais sobre você. 2 - Faça uma pergunta sobre algo que apenas profissionais regulatórios no Brasil saberiam responder. Esta ...

Interesting read on the possible future of the EU medical devices regulations - https://medtech.pharmaintelligence.informa.com/MT148209/Should-The-EU-Establish-A-Central-Accountable-Managing-Structure-For-Medical-Devices As mentioned, Ernest & Young is performing a "Study on Regulatory Governance and ...