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Life Sciences and Healthcare

Products without an intended medical purpose: EU clarifies conditions

Non-medical product manufacturers have limited time to prepare for new risk management and clinical data obligations

20/12/2022

Read time 4m

Life Sciences and Healthcare

Regulatory Horizons Council makes recommendations to UK government for the regulation of AI as a medical device

'Urgent need to get the regulation right' says RHC report which recommends an increase in regulatory capacity and capability to...

12/12/2022

Read time 4m

Life Sciences and Healthcare

UK lays out roadmap for regulation of software and AI as medical devices

What 'deliverables' does the MHRA want from its roadmap and what can be expected from its work packages?

28/10/2022

Read time 5m

Life Sciences and Healthcare

MHRA moves to assuage medical device manufacturers over UK's post-Brexit plans

Businesses will have more time to prepare for the new UKCA marking regime and comment on draft medical device regulations

26/10/2022

Read time 2m

Life Sciences and Healthcare

Zantac clash is reminder for life sciences industry of need for litigation strategies

Robust defences are critical when litigation concerns one product but multiple claimants and jurisdictions

26/08/2022

Read time 6m

Life Sciences and Healthcare

Updated CQC guidance has implications for the health technology and wellbeing industries

Reworked guidance reflects the evolution in models for healthcare service delivery, especially with regard to technological innovation

08/07/2022

Read time 3m

Life Sciences and Healthcare

Products without an intended medical purpose: EU clarifies conditions

Non-medical product manufacturers have limited time to prepare for new risk management and clinical data obligations

20/12/2022

Read time 4m

Life Sciences and Healthcare

Regulatory Horizons Council makes recommendations to UK government for the regulation of AI as a medical device

'Urgent need to get the regulation right' says RHC report which recommends an increase in regulatory capacity and capability to...

12/12/2022

Read time 4m

Life Sciences and Healthcare

UK lays out roadmap for regulation of software and AI as medical devices

What 'deliverables' does the MHRA want from its roadmap and what can be expected from its work packages?

28/10/2022

Read time 5m

Life Sciences and Healthcare

MHRA moves to assuage medical device manufacturers over UK's post-Brexit plans

Businesses will have more time to prepare for the new UKCA marking regime and comment on draft medical device regulations

26/10/2022

Read time 2m

Life Sciences and Healthcare

Zantac clash is reminder for life sciences industry of need for litigation strategies

Robust defences are critical when litigation concerns one product but multiple claimants and jurisdictions

26/08/2022

Read time 6m

Life Sciences and Healthcare

Updated CQC guidance has implications for the health technology and wellbeing industries

Reworked guidance reflects the evolution in models for healthcare service delivery, especially with regard to technological innovation

08/07/2022

Read time 3m

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Health Check

Article list

Products without an intended medical purpose: EU clarifies conditions

Regulatory Horizons Council makes recommendations to UK government for the regulation of AI as a medical device

UK lays out roadmap for regulation of software and AI as medical devices

MHRA moves to assuage medical device manufacturers over UK's post-Brexit plans

Zantac clash is reminder for life sciences industry of need for litigation strategies

Updated CQC guidance has implications for the health technology and wellbeing industries

Products without an intended medical purpose: EU clarifies conditions

Regulatory Horizons Council makes recommendations to UK government for the regulation of AI as a medical device

UK lays out roadmap for regulation of software and AI as medical devices

MHRA moves to assuage medical device manufacturers over UK's post-Brexit plans

Zantac clash is reminder for life sciences industry of need for litigation strategies

Updated CQC guidance has implications for the health technology and wellbeing industries

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