Streamlining Your Path to Compliance: Expert BEP and BER Services
Understanding the Importance of BEP and BER in MDR Compliance Navigating the stringent requirements of the European Medical Device Regulation (MDR, EU 2017/745) requires a structured and comprehensive approach to biological evaluation. Two key documents essential...
Crafting a Comprehensive Biological Evaluation Report (BER) for MDR Compliance
Understanding the Biological Evaluation Report (BER) Ensuring the biological safety of a medical device is a crucial aspect of meeting the European Medical Device Regulation (MDR, EU 2017/745) requirements. At the heart of this process is the Biological Evaluation...
Mastering the Biological Evaluation Plan (BEP) for MDR Compliance
Understanding the Biological Evaluation Plan (BEP) Ensuring the biological safety of a medical device is a fundamental requirement under the European Medical Device Regulation (MDR, EU 2017/745). A core component of this process is the Biological Evaluation Plan...
Strategic Decisions: FDA vs. EU-MDR – Which Path to Take First?
Weighing Your Options: FDA vs. EU-MDR Choosing between FDA and EU-MDR approval is not just a regulatory decision—it’s a strategic choice that impacts your time-to-market, costs, and long-term compliance strategy. Each pathway presents unique benefits and...
Expanding Global Market Access with FDA Approval
How FDA Approval Can Open Doors to International Markets Securing approval from the U.S. Food and Drug Administration (FDA) is a significant milestone for medical device manufacturers. Beyond allowing entry into the U.S. market, FDA approval can also serve as a...
What EU Companies Need to Know About FDA Approval
Transitioning from EU-MDR to FDA: Key Considerations For European medical device manufacturers, entering the U.S. market requires an understanding of the regulatory landscape governed by the U.S. Food and Drug Administration (FDA). While both FDA and EU-MDR (EU...
Understanding FDA’s 510(k) and De Novo Pathways for Faster Market Access
Navigating FDA’s Faster and Cost-Effective Approval Routes When bringing a medical device to market, manufacturers must carefully consider the regulatory pathway that best suits their product and business strategy. The U.S. Food and Drug Administration (FDA) offers...
FDA vs. EU-MDR: Key Differences in Medical Device Regulations
Navigating the Regulatory Landscape for Medical Devices Bringing a medical device to market requires compliance with regulatory frameworks that ensure safety, performance, and quality. Two of the most important regulatory systems in the industry are those governed...
