fda release
Mon
Jul, 27 2026
FDA Medical Device Submissions: Strategic Insights for Success
The regulatory landscape for medical devices is shifting rapidly. Over the last 18 months, significant...
Sat
Apr, 18 2026
ISO 14155:2026 – What the New Edition Means for Medical Device Clinical Investigations
Staying up to date in the medical device industry can be challenging, with regulatory expectations...
Mon
Apr, 14 2025
How to Identify a Predicate Device for 510(k) Notification
A predicate device is defined as a medical device previously approved by the US Food...
Wed
Dec, 18 2024
FDA Process Verification Versus Process Validation
The medical device manufacturing industry is heavily regulated worldwide. This stringent oversight ensures that every...
Fri
Sep, 20 2024
Food and Drug Administration (FDA) – Quality Audits and Inspections
FDA ensures that the medical products placed inside the U.S. market comply with its strict...
Tue
Aug, 20 2024
FDA Labeling and Instructions for Use – Medical Devices
Under the FDA, the Quality System regulations have requirements regarding Good Manufacturing Practice (GMP). To...
Sat
Aug, 17 2024
Combination Products’ Compliance Management in the USA
Medical devices have come a long way to innovation and advancement. With the identification of...
Tue
Jul, 30 2024
FDA’s Human Factors Engineering (HFE) and Usability Testing
The area of medical device research and development known as “human factors and usability” measures...
Thu
Jul, 25 2024
FDA’s Post-Market Surveillance and Reporting for Medical Devices
Medical device manufacturing is a lucrative sector. However, it requires strict vigilance and must be...
Mon
Jul, 15 2024
FDA Medical Device Classes and Approval Routes
The US Food and Drug Administration has established rigorous screening processes for the medical devices...
Thu
Jul, 11 2024
Quality System Regulations (QSR) and Good Manufacturing Practices (cGMP)
In the medical device industry, the idea of quality is not new. To maintain a...
Sun
Jun, 30 2024
Understanding FDA Approval & Regulations for Medical Devices
The medical device manufacturing industry is quite a lucrative sector. However, it is one of...
