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Medical Devices
Global Clinical Evaluation Reports
Reglysis specializes in preparing Global Clinical Evaluation Reports (CER) for medical devices, a critical component of regulatory compliance. CERs involve a detailed assessment of clinical data to evaluate the safety and performance of a medical device. We follow international guidelines to ensure the documentation meets global regulatory requirements, supporting product approval and market access. Our expertise guarantees that all clinical evidence is robust, well-documented, and aligned with the latest standards.
Clinical Literature Review & Data Collection
Safety and Performance Data Analysis
Benefit-Risk Analysis for Medical Devices
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Development of Clinical Evaluation Plans (CEP)
Periodic CER Updates & Revisions
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Compliance with MDR (Medical Device Regulation) & IVDR (In Vitro Diagnostic Regulation)
Expert Report Writing & Peer Review
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Post-Market Clinical Follow-Up (PMCF) Integration
Medical Device Global Consulting
Reglysis provides expert consulting services to navigate the complexities of the global medical device regulatory landscape. Our Global Consulting solutions guide manufacturers through every stage of the medical device lifecycle, from product development and regulatory strategy to market approval and post-market compliance. With our in-depth knowledge of international regulations, we help ensure products meet the stringent requirements of global markets, facilitating smoother approvals and successful commercialization.
Regulatory Strategy & Pathway Planning
Market Access Consultation for Global Regions
Preparation for Regulatory Audits & Inspections
Guidance on CE Marking & FDA Approval
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Quality Management System (QMS) Development & Support
Risk Management & Hazard Analysis
Support for Technical File & Design Dossier Preparation
Post-Market Surveillance & Vigilance Consulting
European Union (EU) Authorized Representative Services
Reglysis offers EU Authorized Representative services to assist non-EU medical device manufacturers in complying with European Union regulations. As an appointed representative, we act as an official liaison between manufacturers and the European regulatory authorities, ensuring that products meet EU requirements for safety and performance. Our services support seamless market entry, help maintain compliance with EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), and ensure ongoing regulatory obligations are met.
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Appointment as EU Authorized Representative
Market Access Consultation for Global Regions
Regulatory Communication with European Authorities
Coordination of Technical Documentation Submission
Vigilance & Post-Market Surveillance Support
Registration of Medical Devices with Competent Authorities
Handling Incident Reporting & Adverse Event Management
Support for CE Marking & Conformity Assessment
Post-Market Surveillance
Reglysis provides comprehensive Post-Market Surveillance (PMS) services to ensure the ongoing safety and performance of medical devices once they are in the market. Our PMS solutions include monitoring and evaluating product performance, collecting adverse event data, and ensuring compliance with regulatory requirements. We help manufacturers identify and mitigate risks, ensuring continuous compliance with global regulatory standards and safeguarding patient health throughout the product's lifecycle.
Adverse Event Reporting & Management
Post-Market Clinical Follow-up (PMCF)
Risk Management & Mitigation Strategies
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Periodic Safety Update Reports (PSUR) & Post-Market Reports
Continuous Monitoring of Product Performance
Customer Feedback & Complaint Handling
Regulatory Compliance for Post-Market Activities
Analysis of Field Safety Corrective Actions (FSCA)
Global Surveillance Data Integration & Reporting
Partner
With Us
By partnering with Reglysis, you ensure that your product progresses smoothly from development to market, minimizing delays and expediting regulatory approvals.