Streamlined Regulatory Pathways for Medical Devices in Europe and the US
Fast-Track Regulatory Approval for Medical Devices in Europe & the US
Navigating medical device regulations
Our expert team streamlines your regulatory journey, providing tailored compliance roadmaps, classification guidance, and end-to-end support for MDR, IVDR, CE Marking, and FDA pathways like 510(k), De Novo, and PMA.
For medical devices in Europe and the US
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.
Efficient Regulatory Pathway Identification
We identify the most efficient regulatory pathways for medical devices in Europe and the US, ensuring compliance and market readiness.
Customized Compliance Roadmaps
Tailored compliance roadmaps provide clear steps for regulatory approval, ensuring timely adherence to all standards and guidelines.
ISO 13485 Compliance Excellence
Comprehensive support for ISO 13485 compliance enhances product reliability and aligns your quality management system with top international standards.
Regulatory Pathway Identification
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.
Europe:
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.
US:
FDA Regulatory Pathways
510(k) Premarket Notification
De Novo Classification
Premarket Approval (PMA)
Compliance Roadmap Tailored to Device-Specific Requirements
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.
Standards and Regulations:
- ISO 13485: Quality Management Systems
- ISO 14971: Risk Management
- Device-specific Guidelines
Services:
- Initial Gap Assessment
- Compliance Strategy Development
- Ongoing Regulatory Updates
Compliance Roadmap Tailored to Device-Specific Requirements
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.
Services:
- Initial Gap Assessment
- Compliance Strategy Development
- Ongoing Regulatory Updates
Services:
- Initial Gap Analysis
- QMS Documentation (Quality Manuals, SOPs, Work Instructions)
- Process Controls and Risk Management Procedures
Develop Robust ISO 13485 Compliance Strategies
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.
Ensure Compliance with FDA's Quality System Regulation (QSR)
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.
Services:
- Quality Policies and Procedures Development
- Documentation and Record-Keeping
- Internal Audits and Staff Training
Regulations:
- EU Medical Device Regulation (MDR)
- In Vitro Diagnostic Regulation (IVDR)
Services:
- Conformity assessment
- Technical file preparation
- Clinical Evaluation Report (CER)
- Risk management documentation
Achieve CE Marking for Successful Market Entry in Europe
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
Secure FDA Clearance and Approval for US Market Access
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.
Pathways
- 510(k) premarket notification
- De Novo classification
- Premarket Approval (PMA)
Services
- Regulatory assessments
- Submission preparation
- FDA interaction management
Ready to streamline your regulatory compliance and get your medical device to market faster?
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