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  UK | NICE’s New Early Value Assessment for Medtech

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  UK | NICE’s New Early Value Assessment for Medtech

  2022, Diagnostics, Digital Health, HTA, June 2022, Medical Devices, Members-Only, Moderate Update, RWD to Support Reg Decisions, UK
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UK | NICE’s New Early Value Assessment for Medtech

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UK | NICE’s New Early Value Assessment for Medtechstuart.mccully2022-08-07T16:28:28+00:00

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  FINLAND | New Article 82 MDR Regulation

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  FINLAND | New Article 82 MDR Regulation

  2022, April 2022, EU, Finland, MDR, Medical Devices, Members-Only, Moderate Update
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FINLAND | New Article 82 MDR Regulation

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FINLAND | New Article 82 MDR Regulationstuart.mccully2022-08-07T16:36:11+00:00

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  China | CMD Publishes 2022 China NMPA (CFDA) Blue Book: Revised Medical Device and IVD Regulation

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  China | CMD Publishes 2022 China NMPA (CFDA) Blue Book: Revised Medical Device and IVD Regulation

  2022, China, February 2022, Medical Devices, Members-Only, Moderate Update
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China | CMD Publishes 2022 China NMPA (CFDA) Blue Book: Revised Medical Device and IVD Regulation

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China | CMD Publishes 2022 China NMPA (CFDA) Blue Book: Revised Medical Device and IVD Regulationstuart.mccully2022-08-07T16:44:24+00:00

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  USA – Real-World Evidence Landscape Review: Insights on the Use of RWE from Stakeholders Across the Medical Device Ecosystem

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  USA – Real-World Evidence Landscape Review: Insights on the Use of RWE from Stakeholders Across the Medical Device Ecosystem

  2022, January 2022, Medical Devices, Members-Only, Minor Update, RWD to Support Reg Decisions, USA
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USA – Real-World Evidence Landscape Review: Insights on the Use of RWE from Stakeholders Across the Medical Device Ecosystem

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USA – Real-World Evidence Landscape Review: Insights on the Use of RWE from Stakeholders Across the Medical Device Ecosystemstuart.mccully2022-08-07T16:49:18+00:00

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  USA – Independent assessment of the NESTcc Test-Cases: RAND Interim Report Provides Insights from RWE Generation for Medical Devices

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  USA – Independent assessment of the NESTcc Test-Cases: RAND Interim Report Provides Insights from RWE Generation for Medical Devices

  2022, January 2022, Medical Devices, Members-Only, Minor Update, RWD to Support Reg Decisions, USA
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USA – Independent assessment of the NESTcc Test-Cases: RAND Interim Report Provides Insights from RWE Generation for Medical Devices

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USA – Independent assessment of the NESTcc Test-Cases: RAND Interim Report Provides Insights from RWE Generation for Medical Devicesstuart.mccully2022-08-07T16:50:26+00:00

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  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
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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

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  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
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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

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  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
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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

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  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
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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

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  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
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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