From 510(k) to PMA: How FDA Consultants Help You Choose the Right Path
Bringing a medical device to market in the United States is a complex and highly regulated process. One of the earliest and most critical decisions a manufacturer must make is selecting the correct FDA regulatory pathway – whether it’s the traditional 510(k)...
How Real-World Evidence Supports Stronger PMCF Reports
Under the European Medical Device Regulation (EU MDR 2017/745), Post-Market Clinical Follow-up (PMCF) has become a cornerstone of continued compliance and safety assurance for medical devices. One of the most powerful tools manufacturers now have at their disposal to fu...
How Early Regulatory Strategy Shapes Faster Drug Approvals
The race to bring new therapies to market is more competitive than ever. For pharmaceutical companies, time is not just money – it’s also life-saving potential, investor confidence, and long-term viability. One often overlooked yet critical factor in this race is ...
SOTA in Context of New Medical Device Regulations
The term State of the Art (SOTA) has taken on renewed significance under the EU Medical Device Regulation (EU MDR 2017/745) and other evolving global frameworks. While SOTA has always played a critical role in product development and safety, the MDR formalizes its relev...
Medical Writing Services: Essential for Pharma & Regulatory Success
Medical writing is a vital component of the life sciences industry, transforming complex scientific data into clear, actionable information. It serves as the bridge between research and real-world application, supporting critical decisions by healthcare professionals, r...
