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Archive for month: December, 2017

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FDA Deliver Final Guidance on the Clinical Evaluation of Software as a Medical Device (SaMD)

US FDA final guidance on clinical evaluation of software as a medical device (SaMD) is now published 

 

The guidance is based on the Medical Device Regulators Forum (IMDRF) SaMD Worknig Group and according to the agency they will be used to develop more specific SaMD clinical evaluation guidance in the future.

Goals of SaMD clinical evaluation

According to the guidance, effective SaMD clinical evaluation should include three major components:

 

  • Valid clinical association between a SaMD’s output and its targeted clinical condition
  • Analytical validation showing that a SaMD correctly processes input data and generates accurate, reliable and precise output data
  • Clinical validation showing that using a SaMD’s output data achieves the product’s intended purpose in terms of clinical care

Emergo, US Medical Device blog

For further information or consultation with our experts reach out to us on [email protected] or call the team on +44 1244 287 900.

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Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU

 

The European Medicines Agency (EMA) and the European Commission have published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s withdrawal from the European Union (EU).

Companies are reminded to plan in advance for the situation that the United Kingdom (UK) will leave the EU on 29 March 2019 in order to avoid any impact on the continuous supply of medicines for human and veterinary use within the EU.

The European Medicines Agency

To access this guidance please follow this link.

To find out the impact of the UK leaving the EU on your business please reach out to our experts here at Instem, reach out to us on [email protected] or call the team on +44 1244 287 900.

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