SOTA in Context of New Medical Device Regulations
The term State of the Art (SOTA) has taken on renewed significance...
Challenges and Solutions in eIFU Implementation
While electronic Instructions for Use (eIFU) offer a wide range of...
Common Compliance Mistakes in eIFU Implementation and How to Avoid Them
As the medical device industry rapidly shifts toward digital solut...
The Benefits of Using eIFU for Medical Device Manufacturers
In the rapidly evolving landscape of healthcare and medical device...
Medical Devices: Integrating RWE into CER for Post-market Devices
Introduction to Clinical Evaluation Reports (CERs)What is a Clinic...
FDA Guidance on AI-Enabled Device Software – Life Cycle and Market Submission
In January 2025, the U.S. Food and Drug Administration (FDA) relea...
