Medical Devices Archives - Page 5 of 6

USA – NESTcc publishes Data Quality Maturity Model Self-Assessment Tools to complement initial Data Quality Framework
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USA – NESTcc publishes Data Quality Maturity Model Self-Assessment Tools to complement initial Data Quality Framework

2022, January 2022, Medical Devices, Members-Only, Minor Update, USA

USA – NESTcc publishes Data Quality Maturity Model Self-Assessment Tools to complement initial Data Quality Framework

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USA – NESTcc publishes Data Quality Maturity Model Self-Assessment Tools to complement initial Data Quality Frameworkstuart.mccully2022-08-07T16:51:09+00:00

USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluation
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USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluation

2022, January 2022, Medical Devices, Members-Only, Moderate Update, USA

USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluation

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USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluationstuart.mccully2022-08-07T16:54:16+00:00

USA | Draft FDA Guidance on the Correct Definition of a ‘Device’
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USA | Draft FDA Guidance on the Correct Definition of a ‘Device’

2021, December 2021, Medical Devices, Members-Only, Minor Update, USA

USA | Draft FDA Guidance on the Correct Definition of a ‘Device’

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USA | Draft FDA Guidance on the Correct Definition of a ‘Device’stuart.mccully2022-08-07T16:56:09+00:00

USA – The FDA Launches its First FDA Video Focused on Patient Cybersecurity Best Practices
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USA – The FDA Launches its First FDA Video Focused on Patient Cybersecurity Best Practices

2021, Medical Devices, Members-Only, Minor Update, October 2021, USA

USA – The FDA Launches its First FDA Video Focused on Patient Cybersecurity Best Practices

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USA – The FDA Launches its First FDA Video Focused on Patient Cybersecurity Best Practicesstuart.mccully2022-08-07T17:07:01+00:00

USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Development
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USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Development

2021, AI, Medical Devices, Members-Only, Moderate Update, October 2021, USA

USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Development

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USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Developmentstuart.mccully2022-08-07T17:12:00+00:00

USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
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USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

2021, AI, Medical Devices, Members-Only, Minor Update, September 2021, USA

USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

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USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devicesstuart.mccully2022-08-07T17:16:19+00:00

UK – MHRA: Software and AI as a Medical Device Change Programme
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UK – MHRA: Software and AI as a Medical Device Change Programme

2021, AI, Medical Devices, Members-Only, Minor Update, September 2021, UK

UK – MHRA: Software and AI as a Medical Device Change Programme

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UK – MHRA: Software and AI as a Medical Device Change Programmestuart.mccully2022-08-07T17:17:15+00:00

UK – MHRA Launches Public Consultation on Future of Medical Device Regulation
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UK – MHRA Launches Public Consultation on Future of Medical Device Regulation

2021, MDR, Medical Devices, Members-Only, Moderate Update, September 2021, UK

UK – MHRA Launches Public Consultation on Future of Medical Device Regulation

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UK – MHRA Launches Public Consultation on Future of Medical Device Regulationstuart.mccully2022-08-07T17:19:47+00:00

Finland – Laws Supplementing EU Regulations on Medical Devices Come into Force
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Finland – Laws Supplementing EU Regulations on Medical Devices Come into Force

2021, Finland, MDR, Medical Devices, Members-Only, September 2021, Significant Update

Finland – Laws Supplementing EU Regulations on Medical Devices Come into Force

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Finland – Laws Supplementing EU Regulations on Medical Devices Come into Forcestuart.mccully2022-08-07T17:23:00+00:00

EU | Guidance on Implant Cards for Medical Devices
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EU | Guidance on Implant Cards for Medical Devices

2021, EU, June 2021, MDR, Medical Devices, Members-Only, Minor Update

EU | Guidance on Implant Cards for Medical Devices

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EU | Guidance on Implant Cards for Medical Devicesstuart.mccully2022-08-07T17:29:18+00:00

USA – NESTcc publishes Data Quality Maturity Model Self-Assessment Tools to complement initial Data Quality Framework

USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluation

USA | Draft FDA Guidance on the Correct Definition of a ‘Device’

USA – The FDA Launches its First FDA Video Focused on Patient Cybersecurity Best Practices

USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Development

USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

UK – MHRA: Software and AI as a Medical Device Change Programme

UK – MHRA Launches Public Consultation on Future of Medical Device Regulation

Finland – Laws Supplementing EU Regulations on Medical Devices Come into Force

EU | Guidance on Implant Cards for Medical Devices

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