We provide detailed assessments, classification guidance, and strategic advice tailored to your device, ensuring a streamlined approval process and reduced regulatory risks.
Navigating the complex regulatory landscape for medical devices in Europe and the US requires precision and informed strategies.
Our team specializes in identifying the most efficient regulatory pathways to ensure compliance and market readiness.
We identify the most efficient regulatory pathways for medical devices in Europe and the US, ensuring compliance and market readiness.
Tailored compliance roadmaps provide clear steps for regulatory approval, ensuring timely adherence to all standards and guidelines.
Comprehensive support for ISO 13485 compliance enhances product reliability and aligns your quality management system with top international standards.
Our team specializes in identifying the most efficient
regulatory pathways to ensure compliance and market readiness.
Streamline Your Compliance with MDR, IVDR, and CE Marking. Our services include detailed assessments, classification guidance, and strategic advice tailored to your device, ensuring a streamlined approval process.
Medical Device Regulation (MDR)
In Vitro Diagnostic Regulation (IVDR)
CE Marking Requirements
Compliance with the FDA's regulatory pathways is crucial for entering the US market. We offer expertise in navigating the 510(k) premarket notification, De Novo classification, and Premarket Approval (PMA) processes.
FDA Regulatory Pathways
510(k) Premarket Notification
De Novo Classification
Premarket Approval (PMA)
Creating a compliance roadmap tailored to your medical device’s unique requirements is crucial for regulatory success.
Our customized roadmaps outline essential steps and milestones for achieving regulatory approval.
Our approach ensures a clear, actionable path to compliance, helping you avoid delays and meet all regulatory expectations.
Creating a compliance roadmap tailored to your medical device’s unique requirements is crucial for regulatory success.
Our customized roadmaps outline essential steps and milestones for achieving regulatory approval.
Our approach ensures a clear, actionable path to compliance, helping you avoid delays and meet all regulatory expectations.
ISO 13485 is the globally recognized standard for quality management systems in the medical device industry.
Benefits:
Enhanced Product Reliability,
Regulatory Alignment and Continuous Improvement
We offer comprehensive support to develop and implement robust ISO 13485 compliance strategies. Our strategies ensure your QMS meets the highest standards of quality and safety, supporting your business goals.
21 CFR Part 820: Quality System Regulation:
Ensuring compliance with the FDA's Quality System Regulation (QSR) is mandatory for marketing medical devices in the US.
We provide tailored QSR compliance strategies to align your QMS with FDA requirements.
Our expertise helps you navigate the complexities of FDA regulations, ensuring your products meet stringent quality and safety standards.
Achieving CE Marking is essential for entering the European market
. We provide end-to-end support in developing strategies for CE Marking, ensuring compliance with EU regulations such as the MDR and IVDR
Navigating the FDA's clearance and approval processes requires strategic planning and thorough preparation.
We develop tailored strategies for obtaining FDA clearance or approval for your medical devices, ensuring timely market access.