SOPs, Plans and Report templates for Clinical Evaluation of EU MDR

#1
Dear all

I am looking for SOPs, plans and report template for Clinical Evaluation related matters of MDR (i.e. Clinical Investigation, PMS, PMCF, CER, PSUR etc.) Does anyone have these I can use?

If not, I see that A.P.Lyon (from the US it seems) are selling SOPs for the entire Clinical Evaluation bundle. Does anyone know if they are good enough? They say they are both MDR and MDDEV compliant so am a little concerned if they truly are MDR compliant).
Thanks for your help.
 
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#3
Dear all

I am looking for SOPs, plans and report template for Clinical Evaluation related matters of MDR (i.e. Clinical Investigation, PMS, PMCF, CER, PSUR etc.) Does anyone have these I can use?

If not, I see that A.P.Lyon (from the US it seems) are selling SOPs for the entire Clinical Evaluation bundle. Does anyone know if they are good enough? They say they are both MDR and MDDEV compliant so am a little concerned if they truly are MDR compliant).
Thanks for your help.
Hi Malik,
Did you end up buying A.P Lyon procedures? Please let us know if they're good so we can look into their SOP's. Thanks!
 
#8
Olá ,
Meu nome é Giovanna Miranda, sou gerente de qualidade em uma empresa de produtos de saúde no Brasil. Estamos nos adaptando à transição para o novo MDR, infelizmente aqui no Brasil há escassez de treinamento e estamos muito confusos com a documentação. Você poderia me ajudar com exemplos de palavras? Somente a estrutura que cada documento deve ter. Se for possível, no formato word, o modelo, por favor.
Plano e relatório do PMS
Plano e relatórios do PMCF
Plano e relatório do PMV
Exemplo de declaração de interesse individual do pessoal clínico responsável pela avaliação clínica.
Meu e-mail: [email protected]
Agradecemos antecipadamente a sua atenção e ajuda, será muito bem-vindo.

obrigado
 
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