Medical Device Design
Medical device design should consider – at the earliest of design stages – manufacturing licence application requirements, regulatory compliance requirements, material supply chains and reactivity, and manufacturing at scale.
Medical device design should consider – at the earliest of design stages – manufacturing licence application requirements, regulatory compliance requirements, material supply chains and reactivity, and manufacturing at scale.
Are you ‘recall ready’? What do regulators such as the FDA, TGA, EMA or MHRA expect in terms of recall preparedness? Recall basics.
Medicine supply shortages relating to the pandemic continue to wreak havoc on treatment continuity. GMP education can help reduce shortages caused by …
Batch release decisions — and other product safety evaluations — rely on data integrity. In this pharmaceutical industry…
Get ready for an audit (how to train your employees) Need to get ready for an audit? How…
Remote inspections: FAQs Remote Inspections & Offsite Auditing 10 Commandments for Conducting Remote Inspections (offsite inspections) FAQ 1:…
FAQs about Software as a Medical Device (SaMD) Medical-purpose software development is a rapidly growing industry. As with…
New online courses available for clinical trials and GCP compliance training. The latest online training courses at www.onlinegmptraining.com…
Lean manufacturing and ‘just in time’ shipping strategies means medical supply chain risks are an ever-present phenomenon. But medical…
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