US FDA The Regulatory Divide: Medical Devices vs. Drugs under US FDA Regulations bySCIENCE ARENA -February 25, 2024 The distinction between medical devices and drugs is fundamental yet often misunderstood. While …
Quality Management System ETO Sterilization - Sterilization of Health Care Products Using Ethylene Oxide - A Guide to Industry Practices & Regulatory Requirements bySCIENCE ARENA -February 25, 2024 In the healthcare industry, ensuring the safety and efficacy of medical devices is paramount. St…
CDSCO Audit by Licensing Authority | Central Drugs Standard Control Organisation | Medical Device Rules 2017 bySCIENCE ARENA -February 07, 2024 In Order to regulate the medical device and IVD industry, the Govrenment of India introduced the…
Quality Management System ISO and IEC standards for software in medical devices bySCIENCE ARENA -February 06, 2024 In the ever-evolving landscape of healthcare technology, software plays an increasingly integra…
Audit Certification Audit - an auditee's perspective bySCIENCE ARENA -February 05, 2024 Certification audits play a pivotal role in ensuring that organizations comply with established …