05
Apr
SaMD Digital Technology Assessment Criteria (DTAC)
The integration of digital technologies into healthcare systems represents both tremendous opportunity and sig...
05
Apr
SaMD Post-Market Surveillance
Post-market surveillance (PMS) represents a critical phase in the lifecycle of medical devices, including Soft...
05
Apr
MHRA Registration and Approved Bodies for SaMD
MHRA Registration
The Medicines and Healthcare products Regulatory Agency (MHRA) registration is a mandator...
05
Apr
Clinical Evaluations & Clinical Investigations for SaMD Development
Clinical evaluations and investigations form critical components of the medical device regulatory pathway, par...
01
Apr
Conformity Assessment Route for Class III SaMD
Software as a Medical Device (SaMD) classified as Class III represents the highest risk category and follows t...
01
Apr
Conformity Assessment Route for Class IIb SaMD
Software as a Medical Device (SaMD) classified as Class IIb represents a higher risk category and follows a sp...
01
Apr
Conformity Assessment Route for Class IIa SaMD
Software as a Medical Device (SaMD) that falls into the Class IIa risk category must follow a specific conform...
01
Apr
Conformity Assessment Route for Class I SaMD
Introduction
Class I SaMDs represent the lowest risk category within the medical device classification syst...
01
Apr
Essential General Requirements for Software as a Medical Device (SaMD) Conformity Assessment
The conformity assessment process for Software as a Medical Device (SaMD) requires adherence to essential gene...
01
Apr
Conformity Assessment Routes for Software as a Medical Device (SaMD)
The regulatory approval process for Software as a Medical Device (SaMD) follows specific conformity assessment...
