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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
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Medical Device and FDA Regulations and Standards News
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Medical Device News
DHS – Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients
Marcelo
Jan 7, 2019
Replies
0
Views
344
Jan 7, 2019
Marcelo
M
Informational
Webinar: The role of the TGA in digital health
Marcelo
Jan 7, 2019
Replies
0
Views
276
Jan 7, 2019
Marcelo
M
Medical Device News
TGA Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy
Marcelo
Jan 7, 2019
Replies
0
Views
383
Jan 7, 2019
Marcelo
M
Medical Device News
TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia
Marcelo
Jan 7, 2019
Replies
0
Views
374
Jan 7, 2019
Marcelo
M
Medical Device News
MHRA releases response to consultation on EU exit no-deal legislative proposals
Marcelo
Jan 3, 2019
Replies
0
Views
332
Jan 3, 2019
Marcelo
M
Pharmaceuticals News
UK – Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal
Marcelo
Jan 3, 2019
Replies
0
Views
441
Jan 3, 2019
Marcelo
M
Medical Device News
ANVISA – Consulta Pública nº 586 de 20/12/2018 – Diretrizes de Garantia da Qualidade para Validação, Monitoramento e Controle de Rotina dos Processos
Marcelo
Dec 21, 2018
Replies
0
Views
426
Dec 21, 2018
Marcelo
M
Medical Device News
ANVISA – Consulta Pública nº 585 de 20/12/2018 – Boas Práticas para o Processamento de Produtos utilizados na assistência à saúde
Marcelo
Dec 21, 2018
Replies
0
Views
345
Dec 21, 2018
Marcelo
M
Medical Device News
ANVISA – Consulta Pública nº 584 de 20/12/2018 – Enquadramento de dispositivo médico como de uso único ou reutilizável
Marcelo
Dec 21, 2018
Replies
0
Views
329
Dec 21, 2018
Marcelo
M
Medical Device News
MedTech Europe Statement on the Implant Files
Marcelo
Dec 21, 2018
Replies
0
Views
336
Dec 21, 2018
Marcelo
M
Medical Device News
CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation
Marcelo
Dec 21, 2018
Replies
0
Views
402
Dec 21, 2018
Marcelo
M
FDA News
Safety Alert – USFDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation
Marcelo
Dec 21, 2018
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0
Views
377
Dec 21, 2018
Marcelo
M
FDA News
USFDA Final Report – MDUFA IV Independent Assessment of FDA’s Device Review Process Management
Marcelo
Dec 21, 2018
Replies
0
Views
379
Dec 21, 2018
Marcelo
M
FDA News
Statement from USFDA on steps to strengthen the long-term safety oversight of the Essure device
Marcelo
Dec 21, 2018
Replies
0
Views
329
Dec 21, 2018
Marcelo
M
FDA News
USFDA – Reclassification of Electroconvulsive Therapy Devices
Marcelo
Dec 21, 2018
Replies
0
Views
258
Dec 21, 2018
Marcelo
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
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