Medical Device (SaMD)

MHRA GMP Audit – Summary of 2019 – 2020 Inspections (PQS deficiencies)
Jan
20

MHRA GMP Audit – Summary of 2019 – 2020 Inspections (PQS deficiencies)

Top 10 MHRA GMP Audit deficiencies (2019 – 2020 analysis) Summary article for Education Purposes only. If you are facing a GMP audit by the MHRA, you’ll want to ensure ALL of your quality systems are fully compliant with current Good Manufacturing Practice (cGMP). That noted, which components of your pharmaceutical or medical device quality […]

By Connie May | GMP Audits . Medical Device (SaMD)
DETAIL
Software as a Medical Device (SaMD)
Oct
27

Software as a Medical Device (SaMD)

FAQs about Software as a Medical Device (SaMD) Medical-purpose software development is a rapidly growing industry. As with other medical devices, medical-use software offers potential benefits to patients. SaMD can save lives by improving diagnostic capacities, monitoring treatment efficacy, and guiding critical-care decisions. Review the online GMP compliance course for SaMD designers, medical-use software manufacturers […]

By Connie May | Medical Device (SaMD) . EU GMP Training Online . FDA and EU GMP . FDA Audit . FDA GMP Audit . FDA Inspections . GMP e-Learning Online Courses
DETAIL