ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective...
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Guidance for Device Manufacturers: Artixio guides manufacturers in conducting effective post-market surveillance (PMS) activities.
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Risk Profile Development: Artixio helps develop risk-based PMS strategies tailored to specific medical devices.
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Regulatory Compliance: Artixio identifies and ensures compliance with requirements from EU MDR, IVDR, ISO 13485-2016, 21 CFR Part, and other relevant guidance documents.
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Data Evaluation: Artixio evaluates current PMS data, drawing conclusions to meet new regulatory standards in target markets.
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Structured PMS Documentation: Artixio provides well-structured PMS plans, procedures, and report templates.
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Vigilance Reports: Artixio prepares vigilance reports in compliance with local requirements and ensures timely delivery.
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Regulatory Support: Artixio assists with annual reports and Post Marketing Surveillance reports.
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CAPA Management: Artixio handles corrective and preventive actions (CAPA).
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Product Recall and Complaint Handling: Artixio supports product recalls, customer complaints, and country-specific medical device reporting.
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PMCF Requirements Identification: Artixio identifies requirements for Post-Market Clinical Follow-up (PMCF) from PMS data.
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Device Registration and Investigation Support: Artixio assists with medical device registration, case management, exposure management, and adverse event follow-up.
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Post-Marketing Literature Surveillance: Artixio monitors relevant literature for safety and regulatory assessment.
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Artixio ensures safety, compliance, and continuous improvement in the post-market phase. 🌟🔍🩺
PMS services from Artixio for medical devices and diagnostics involves a range of essential services to ensure ongoing safety, quality, and performance after your products are placed on the market globally. Artixio's services include:
Global Post-market surveillance (PMS)
Leverage Artixio's Global Presence for Compliance
With regional team members based in 70+ countries including key markets such as Japan, China, Singapore, Taiwan, India, USA, EU, Mexico, UAE, Saudi Arabia, Australia and others, Artixio can support your global PMS requirements specific to country regulations.
All our professionals have 10+ years of experience in successfully managing compliance for medical devices in global markets.
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Regional Team in 70+ Countries: Artixio's team has significant experience in respective countries.
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Risk Assessment and Guidance: Artixio proactively monitors complaints to assess risk and advises manufacturers on strategic and tactical activities.
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Smooth PMA to PMS Transition: Artixio ensures a seamless transition from pre-market approval (PMA) to post-market surveillance (PMS).
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Effective Data Utilization: Artixio continuously collects, analyzes, and delivers PMS data, leveraging it for business benefits.
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Xchange - a forum where you can access key insights regarding country specific regulations. You can ask questions where our experts can answer.
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Updates on new regulations and changes in current regulations
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Planning PMS based on country specific regulations.
The regulations around the world are evolving faster for medical devices to ensure accountability and patient safety. Artixio helps you stay ahead with these regulations and their potential impact on your products using its regional team of professionals and network with regional industry associations and health authorities.
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