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Compliance is very critical to the use of safe and effective medic...
Steps to Implement ISO 13485 for New Medical Device Vendors
For medical device vendors entering the industry, obtaining ISO 13...
Clinical Evaluation without Clinical Data in the EU
Application of EU MDR Article 61(10) When Clinical Data is Conside...
Implications of AI on Medical Device Technology and Certification
Currently, AI refers to the ability of machines to perform cogniti...
Pharma/Biotech – USA, Europe and Asia Regulatory Updates Roundup – Sept 2024
USA
FDA Approves Drug with New Mechanism of Action for Treatment o...
Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Sept 2024
USA Air Powered Dental Handpieces and Air Motors – Performance Cri...
