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Writing a Biological Safety Assessment (BSA) report: Premarketing Requirement Risk Assessment

Biological Safety Assessment or BSA as it is called is an important and wide field. As new breakthroughs by way of medicine, crop, biotechnology increase, the need to assess the safety of medical devices becomes paramount. It provides some amount of reassurance to patients in a clinical investigation. A report should be based on medical devices directives-MEDDV 2.7.1 and clinical investigations guidelines ISO 14155.

Writing a Biological Safety Assessment (BSA) report can run as under:

1 Clinical data and Evaluation and Evidence:

The safety and/or performance information that is generated from the clinical use of a device and a procedure to collect, appraise and analyse 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 and an evaluation report pertaining to the medical device.

2 Clinical Investigation, Plan and Performance:

A systematic investigation of one or more human subjects undertaken to assess the safety, a rationale and methodology; behaviour of the medical device or the response of the subjects to the device.

Device Registry:

An organised system that uses observational study methods to collect clinical data under normal conditions of use relating to one or more devices to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure  that serves a predetermined scientific, clinical or policy purpose.

Clinical Safety and Use:

Freedom from unacceptable clinical risks; use of the medical device in or on human subjects.

5 Feasibility Study and Standards:

A clinical investigation that is commonly used to capture preliminary information on a medical device (at an early stage of product design) to adequately plan further steps of device development, including needs for design modifications or parameters; standards whose references have been published in the Official Journal of the European Communities.

6 Hazard due to substances and technology:

Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.

Post Market Clinical Follow up (PMCF) data and plan:

Even products with pre market clinical studies might require PMCF data and plan as a range of sizes may not be covered by clinical studies. Also, certain risks of implantable products cannot be assessed during the normal duration of the clinical study for example ‘how long will an implant last’.

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Writing a Biological Safety Assessment (BSA) report: Premarketing Requirement Risk Assessment


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