Clinical evaluation and risk management

Medical Device Stability Testing

Medical Device Stability Testing Medical Device Stability Testing is conducted to determine the environmental effects such as temperature humidity, light, moisture, pH, agitation, gravity on product strength, quality, and purity. Such testing’s are conducted in the life sciences, chemical, medical devices, IVDs, pharmaceuticals, and food industries. Stability Testing provide supporting evidence to establish product storage…

Clinical evaluation and risk management

Relation between Clinical Evaluation and Risk Management

Relation between Clinical evaluation and risk management are closely intertwined in the context of medical devices. Clinical evaluation is the process of collecting clinical data and evidence to assess the safety and performance of a medical device throughout its lifecycle. This evaluation includes the review of existing clinical literature, clinical investigations, post-market clinical data (PMS),…

What is Medical Device Clinical Evaluation

What is Medical Device Clinical Evaluation

What is Medical Device Clinical Evaluation CE is a methodologically sound ongoing procedure to collect, appraise and analyze the clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions…