Celegence offers a comprehensive Medical Device Complaints Management service designed to streamline complaint intake, evaluation, processing, and reporting.
By leveraging industry best practices and technology-driven insights, Celegence helps manufacturers maintain compliance with evolving complaints management regulations and guidelines, such as FDA 21 CFR Part 820.198, EU MDR and ISO 13485:2016. Our streamlined processes, enable customers to maximize efficiency, reduce manual effort, and minimize operational costs.
Whether supporting post-market surveillance or ensuring global regulatory alignment, Celegence provides the expertise and tools needed for an effective complaints management strategy.
EU MDR Consulting
US FDA Medical Device Services
Management of high-volume and complex complaints with efficiency and regulatory compliance
End-to-end processes to reduce resolution times, improve quality, and uphold regulatory standards
Delivery of standardized documentation, reporting, and tracking to enhance transparency and accountability
Optimization of resource usage to reduce costs and boost overall efficiency
Automation technology to minimize manual tasks and maximise use of resource deploy cross-functional teams, ensuring quality and compliance is maintained when processing complaints
Manager, Medical Device Services
Smridula Hariharan has a Master’s degree in Pharmacy, and over 12 years of experience in Medical Writing for Medical Device Regulatory Affairs as well as pharmacovigilance and clinical research.
She has authored and reviewed post-market surveillance (PMS) documents for medical devices and invitro diagnostics belonging to different risk classes and therapeutic areas.
She has successfully procured CE marking under MDD and MDR for novel as well as legacy products through comprehensive clinical evaluations, PMS plans, and PMCF plans/reports.
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Medical Writer II
Tamanna Sahraya is a skilled medical writer specializing in regulatory documentation for medical devices, with expertise in FDA and EU MDR compliance. She has experience authoring Clinical Evaluation Reports (CER), Post-Market Surveillance Reports (PMSR), and Risk-Benefit Assessments while ensuring adherence to MEDDEV 2.7/1 Rev. 4 and MDR standards.
With a strong background in regulatory affairs, literature reviews, and safety analysis, she supports product lifecycle management and clinical data reporting. Her analytical approach and commitment to compliance help streamline regulatory submissions and enhance client collaboration.
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Medical Writer II
Roderick Shilshi is a regulatory medical writer specializing in medical device compliance under FDA and EU MDR regulations. He has experience authoring Clinical Evaluation Reports (CER), Post-Market Surveillance Reports (PMSR), and Risk-Benefit Assessments, ensuring alignment with MEDDEV 2.7/1 Rev. 4 and MDR standards.
With expertise in literature reviews, safety reporting, and regulatory submissions, he supports product lifecycle management and clinical data analysis. His detail-oriented approach helps maintain compliance and streamline regulatory documentation.
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Senior Medical Writer
Srujana Akkiraju is an experienced medical writer with nearly a decade of expertise in regulatory and clinical documentation. She specializes in authoring and reviewing high-quality regulatory submissions, including CCDS, RMPs, PSURs, and labeling content across multiple therapeutic areas.
At Celegence, she leads a team of medical writers, ensuring compliance with global regulatory standards while optimizing processes for efficiency. With a strong background in scientific writing, quality control, and stakeholder collaboration, she plays a key role in delivering clear, precise, and regulatory-compliant documentation.
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An effective complaints management system is crucial in the medical device industry to protect patient safety and ensure regulatory compliance. Medical devices impact human health, making timely detection, investigation, and resolution of complaints essential.
A structured approach helps:
Poor complaint handling can lead to:
Regulatory bodies like the FDA, European Commission, and Health Canada enforce strict complaint handling and reporting requirements. A proactive system ensures compliance while providing insights into product performance and emerging risks. By leveraging technology and best practices, manufacturers can improve response times, enhance transparency, and build trust with healthcare providers and patients.
CAPTIS® AI Platform for EU MDR and IVDR Compliance
CAPTIS® is a secure, user-friendly web-based application that assists medical writers with the laborious process of creating regulatory documentation for EU MDR / IVDR compliance such as CEP/CER, PEP/PER, SVR, PMCF Plan/Report, SSCPs and more. CAPTIS® has been developed in collaboration with our experienced and qualified team of medical writers to address the real time challenges in medical writing and EU MDR / IVDR compliance.
Learn More About CAPTIS ®
25 Apr, 2025
25 Apr, 2025
25 Apr, 2025
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
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