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Showing posts from June, 2020

Q1. What is Clinical evaluation?

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Q1. What is Clinical evaluation? Ans. Clinical evaluation is a methodologically sound procedure to collect, appraise and analyse clinical data related to a medical device and to assess whether there is sufficient clinical evidence to confirm compliance with the general safety and performance requirements of the device when it  is used as intended by the manufacturer.  it is done, initially to obtain CE marking of the device and for placing the device in the market but updated thereafter periodically as new information becomes available from ongoing research works or literatures published. The  clinical evaluation  is based on a comprehensive analysis of available pre- and post-market clinical data relevant to the intended purpose of the device. There are 4 different stages in performing clinical evaluation: Stage 0: Scoping and planning of clinical evaluation Stage 1:Identification of pertinent data (identifying relevant pre-market and post-market cli...

Scientific Literature search and its importance’s in MEDDEV Rev 4 compliance

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Clinical evaluation is a continuous process used to evaluate the conformity of medical devices to safety and performance requirements, when used as intended by the manufacturer. The role of literature search in clinical evaluation is immense. Literature search is performed to identify clinical data which is not available with the manufacturer, but is critical to the completion of the clinical evaluation. The clinical data identified undergoes a series of stringent checks to assess its suitability before being included in the clinical evaluation. The data obtained from various sources are appraised to evaluate their relevance and contribution, to evaluation of clinical safety and clinical performance. The appraised dataset is then analysed to check if they can be used collectively to demonstrate the compliance of the device to essential requirements. The first step towards conducting a thorough literature search is to prepare a search plan considering the scope of clinical evaluatio...

What is the difference of the Clinical evaluation and clinical investigation?

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Q1. What is the difference of the Clinical evaluation and clinical investigation? Clinical Investigation is a systematic study performed in humans to access the safety and performance of a medical device based on the comprehensive analysis of available preclinical, Clinical (Safety) and post-market data relevant to the intended purpose of the device. Clinical evaluation  is a process to continuously generate, collect, analyse and assess the clinical data pertaining to a medical device under evaluation to prove the conformity with general safety and performance requirements as per its intended use by manufacturer. Q2. When and who is responsible to conduct the clinical evaluation? When- Clinical evaluation is an ongoing process and first conducted during the development stage of medical device throughout its life cycle. Who- Manufacturer is responsible to conduct Clinical evaluation for initial CE-marking. Q3. How is the clinical evaluation related to t...