Turning Clinical Challenges into Market Opportunities.
Medical Device Clinical Project Management – An Overview
Clinical Project Management (CPM) for medical devices is the structured planning, execution, and oversight of clinical investigations to evaluate a device’s safety, performance, and clinical benefits in line with regulatory requirements such as EU MDR 2017/745, US FDA 21 CFR, and India’s Medical Device Rules 2017.
Unlike drug trials, medical device clinical projects often involve smaller patient groups, device-specific endpoints, usability studies, and post-market follow-up. A CRO’s Clinical Project Management team ensures that these studies run efficiently, compliantly, and within timelines.
The RegHelps SRC Clinical Project Management team acts as the backbone of a medical device clinical investigation, from planning and approvals to execution, monitoring, and reporting, ensuring the device reaches market with robust clinical evidence
Key Responsibilities of the CRO Clinical Project Management Team
Why CRO Project Management is Critical for Medical Devices
The RegHelps SRC Clinical Project Management team acts as the backbone of a medical device clinical investigation, from planning and approvals to execution, monitoring, and reporting, ensuring the device reaches market with robust clinical evidence. They ensures the following
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Compliance with MDR, FDA, and CDSCO requirements.
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Mitigates risks through proactive planning and monitoring.
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Improves efficiency, ensuring studies are delivered on time and within budget.
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Protects patient safety and data integrity.
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Provides sponsors with transparent updates and confidence in study outcomes.
With our expertise, sponsors gain a reliable partner who safeguards patient safety, strengthens data integrity, and delivers results on time. Contact us today to discuss your clinical project needs and learn how RegHelps SRC can accelerate your path to regulatory approval and market success.
service related FAQ’s
Any medical device or new in vitro diagnostic medical device that is imported or manufactured for the purpose of clinical investigation, clinical performance evaluation, testing, evaluation, demonstration, or training must be kept in containers with labels clearly indicating:
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Name of the product or code number
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Batch or lot number
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Serial number (wherever applicable)
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Date of manufacture
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Use-before date
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Storage conditions
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Name and address of the manufacturer
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The specific purpose for which it has been manufactured
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“For Clinical Investigation / Evaluation Only – Not for Sale”
Form MD-22: This is the application form submitted to the Central Licensing Authority (CLA) (i.e., DCGI under CDSCO) to seek permission for conducting a clinical investigation of a new medical device or an investigational medical device without a predicate device in India.
Form MD-23: If the CLA is satisfied with the application, it grants permission to conduct the clinical investigation through Form MD-23. This permission allows the sponsor to begin the study in accordance with an approved clinical investigation plan reviewed by a registered Ethics Committee.
Additional requirements:
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The clinical investigation must be registered with the Clinical Trials Registry – India (CTRI) before the enrolment of the first participant.
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The first participant must be enrolled within one year of the grant of permission; otherwise, fresh permission from the CLA is required.
