Medical Product Regulatory

Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments

Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments by Qi Jiang and Weili He
English | 2016 | ISBN: 1482259362 | 312 pages | PDF | 8,3 MB

Handbook of Medical Device Regulatory Affairs in Asia: Second Edition  eBooks & eLearning

Posted by roxul at June 6, 2018
Handbook of Medical Device Regulatory Affairs in Asia: Second Edition

Jack Wong, "Handbook of Medical Device Regulatory Affairs in Asia: Second Edition"
English | ISBN: 9814774316 | 2018 | 654 pages | PDF | 15 MB

Handbook of Medical Device Regulatory Affairs in Asia  eBooks & eLearning

Posted by interes at Oct. 1, 2013
Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia by Jack Wong and Raymond Tong Kaiyu
English | 2013 | ISBN: 9814411213 | ISBN-13: 9789814411219 | 616 pages | PDF | 13,5 MB

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality.
Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments (repost)

Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments by Qi Jiang and Weili He
English | 2016 | ISBN: 1482259362 | 312 pages | PDF | 8,3 MB
Understanding the Role of Economic Operators within the Medical Device Regulatory Sector

Shalinee Naidoo, "Understanding the Role of Economic Operators within the Medical Device Regulatory Sector"
English | ISBN: 1774690845 | 2021 | 265 pages | PDF | 5 MB

Real-world Evidence in Medical Product Development  eBooks & eLearning

Posted by hill0 at May 12, 2023
Real-world Evidence in Medical Product Development

Real-world Evidence in Medical Product Development
English | 2023 | ISBN: 3031263278 | 417 Pages | PDF EPUB (True) | 20 MB
Extractables and Leachables: Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devi

Extractables and Leachables
by Dennis Jenke

English | 2022 | ISBN: ‎ 1119605075 | 457 pages | True EPUB, PDF | 32.51 MB

Global Pharma Drug Regulatory Affairs course  eBooks & eLearning

Posted by ELK1nG at Jan. 10, 2022
Global Pharma Drug Regulatory Affairs course

Global Pharma Drug Regulatory Affairs course
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz
Language: English | Size: 2.21 GB | Duration: 5h 43m

Pharma Drug Regulatory Affairs Course, eCTD, CTD, INDA, NDA, ANDA, DMF, ICH, DRA Course

Artificial Intelligence: Risk Management For Medical Device  eBooks & eLearning

Posted by ELK1nG at Oct. 4, 2024
Artificial Intelligence: Risk Management For Medical Device

Artificial Intelligence: Risk Management For Medical Device
Published 10/2024
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz
Language: English | Size: 495.56 MB | Duration: 1h 4m

Application of AAMI/BSI TR 34971 and ISO 14971​

Production Validation Training In Medical Devices -Iq,Oq -Pq  eBooks & eLearning

Posted by ELK1nG at April 4, 2023
Production Validation Training In Medical Devices -Iq,Oq -Pq

Production Validation Training In Medical Devices -Iq,Oq -Pq
Published 4/2023
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz
Language: English | Size: 948.67 MB | Duration: 1h 6m

Production Validation in Medical Devices- The Installation -The Operation -The Performance (IQ,OQ,PQ) for Production