CLINICAL TRIAL MANAGEMENT
Regulatory Services
Navigating the complex landscape of regulatory requirements can be challenging. Our regulatory experts offer strategic guidance and support to help clients achieve compliance and successful outcomes. From the initial consultation through to the submission of study data, we are with you every step of the way.
Our team’s thorough understanding of regulatory agency requirements ensures that every detail is accounted for, minimizing the risk of delays or setbacks. We work closely with clients to develop tailored strategies that align with their specific needs, making the path to market approval as smooth and efficient as possible.
Regulatory Services:
Our services are designed to help you navigate the complex regulatory landscape for medical devices, ensuring your products meet all necessary standards and achieve successful market entry.
Regulatory Strategy Development
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Designing tailored regulatory strategies for medical devices and software.
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Providing guidance on regional and international regulatory requirements for medical devices, including imaging equipment.
Regulatory Submissions and Approvals
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Preparing and submitting 510(k) premarket notifications.
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Handling Premarket Approval (PMA) applications.
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Submitting De Novo classification requests for novel devices.
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Managing CE Marking submissions for European markets.
Software as a Medical Device (SaMD) Compliance
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Providing regulatory support for Software as a Medical Device (SaMD).
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Ensuring compliance with international standards such as ISO 13485 and IEC 62304.
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Preparing cybersecurity documentation and risk management files.
Ethics Committee and Institutional Review Board (IRB) Submissions
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Preparing and submitting documents for ethics committee and IRB review specific to medical device trials.
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Facilitating communication with ethics committees and IRBs to ensure approval.
Labeling and Packaging Review
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Ensuring compliance of device labeling and packaging with regulatory standards.
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Reviewing and approving labels and instructions for use (IFU) for medical devices and software.
Regulatory Compliance and Audits
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Conducting regulatory compliance audits for medical device manufacturers.
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Providing support during regulatory agency inspections and audits specific to medical devices and software.
Regulatory Intelligence and Gap Analysis
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Conducting regulatory intelligence to stay updated with evolving medical device regulations.
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Performing gap analysis to identify regulatory deficiencies in device documentation and processes.
Training and Support
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Providing regulatory training tailored to medical device and software development teams.
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Offering ongoing regulatory support throughout the device lifecycle.