Regulatory
Be Prepared for Your Journey with The FDA – How to Be Inspection-Ready
February 17, 2025
Continuous Improvement in Compliance Documentation: Learning from Feedback and Iterating for Success
July 31, 2024
Addressing Multilingual and Global Requirements: Best Practices for Translating Compliance Documentation – Overall Best Practices
July 31, 2024
The Perfect Audit Trail
June 11, 2024
Challenges and Solutions for Achieving FDA 21 CFR Part 11 Compliance through CSV and CSA
January 19, 2024
The Future of CSV and CSA in FDA 21 CFR Part 11 Compliance: Trends, Innovations, and Best Practices
July 13, 2023
Guide on How to Pass the FDA’s 5 Stage Goals to Launch Medical Devices to Market
July 10, 2023
IEC 62304 | How to Overcome the Challenges in Medical Device Manufacturing?
May 2, 2023
FDA 21 CFR Part 312-Requirements | Inspection | Audit Checklist
April 18, 2023
21 CFR Part 820 vs ISO 13485(2016) Differences and Similarities
March 10, 2023
FAQs on CSA & CSV: FDA CSA Regulatory Requirements
February 24, 2023
ISO 9001 Document Control Checklist
October 28, 2022