Achieve CE Marking with Comprehensive Technical File Preparation
Seamless CE Marking & FDA Compliance for Medical Devices
Achieving CE Marking and FDA approval
We provide expert guidance in technical file preparation, Device Master Records (DMR) maintenance, and regulatory submissions.
Expert Compliance Support
Seamless Documentation Process
Regulatory Approval Confidence
How does this work?
Technical File Preparation
We compile, review, and submit your technical file for CE Marking.
Regulatory Submission Support
Assistance with 510(k), PMA, and EU MDR documentation to meet compliance.
Ongoing Compliance & Updates
Regular audits, impact assessments, and change control management.
Comprehensive Technical File Setup for CE Marking
Setting up a comprehensive technical file is critical for achieving CE Marking for your medical devices.
We provide end-to-end support for technical file preparation, ensuring regulatory compliance and a smooth submission process.
Standards:
- EU MDR
- In Vitro Diagnostic Regulation (IVDR)
Services:
- Documentation compilation
- Technical file submission
- Regulatory compliance checks
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
Expert Maintenance of Device Master Records (DMR)
Maintaining accurate and up-to-date device master records (DMR) is crucial for regulatory compliance.
We offer support in managing and maintaining your DMRs, ensuring they are compliant and current with regulatory standards.
Standards:
- ISO 13485
- FDA QSR
Services:
- DMR documentation
- Regular updates and reviews
- Compliance checks
Strategic Support for 510(k) Submissions and PMA Applications
Successfully navigating the FDA’s 510(k) and PMA submission processes requires detailed preparation and expertise.
We provide comprehensive support for your regulatory submissions, helping you achieve timely FDA clearance or approval.
Pathways:
- 510(k) premarket notification
- Premarket Approval (PMA)
Services:
- Submission preparation
- Interaction with the FDA
- Response to deficiencies
Develop and Complete the Essential Requirements Checklist for EU
Meeting the essential requirements of the EU MDR is crucial for regulatory compliance.
We provide expert guidance in developing and completing the essential requirements checklist, ensuring your product meets all regulatory standards.
Regulations:
- EU MDR
- In Vitro Diagnostic Regulation (IVDR)
Services:
- Checklist development
- Compliance assessment
- Documentation support
Effective Change Control Process Documentation
Documenting the change control process is vital for maintaining regulatory compliance and product quality.
We offer support in developing and managing change control documentation, ensuring your processes are compliant and well-documented.
Standards
- ISO 13485
- FDA QSR
Services
- Change control documentation
- Process implementation
- Compliance monitoring
Comprehensive Impact Assessment and Implementation Support
Conducting impact assessments and implementing changes effectively is crucial for product quality and regulatory compliance.
We provide comprehensive support for impact assessments and implementation, ensuring successful changes with strategic planning and monitoring.
Services:
- Impact assessment planning
- Implementation strategy development
- Monitoring and evaluation
Reach out to us and achieve CE Marking with Comprehensive Technical File Preparation
Swiss MPC GmbH Riedmatt 2, 6300 Zug, Switzerland
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