The quality standards of medical devices consist of many aspects such as design control, risk management, vendor management etc. In this blog, we are going to discuss the importance of risk management ISO 14971 for medical devices and steps to implement it during the product development stage. ISO 14971 an international standard for risk management related to the manufacturing of medical devices. It is recognized by most regulatory authorities as to the “de facto” standard for risk management. ISO 14971 is an integral part of an effective quality management system and should be embedded in your medical device manufacturing life-cycle process. A solid risk assessment program helps you identify design issues before distribution, eliminating dangerous problems and the costs associated with recalls.
Medical device companies MUST have established risk management processes that comply with ISO 14971.And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. Every international regulatory agency you’ve ever heard of accepts ISO 14971, as the risk management standard for the medical device industry. ISO 14971 is a good standard. Informative and descriptive. Easy (enough) to comprehend.
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ISO 14971 provides a thorough list of key terms and definitions relating to risk management. I will just share a few key definitions in few points.
RISK
The combination of the probability of occurrence of harm and the severity of that harm. Some things can be unpredicted which can cause harm or danger.
HAZARD
A potential source of harm. Hazard can be also stated as the chance or the probability of danger.
HAZARDOUS SITUATION
The circumstance in which people, property, or the environment are exposed to one or more hazard(s). In easy words stated as the danger which can cause harm to anything or anyone.
HARM
Physical injury or damage to the health of people, or damage to property or the environment. Harm can be stated as like harm to a person, animal, or to any other stuff or things.
SEVERITY
The measures of possible consequences of a hazard. The fact or the condition of being severe, or serious and not in a good or normal form.
RISK ANALYSIS
The systematic use of available information to identify hazards and to estimate the risk. A prediction or to assume that the risk can be avoided in certain situations or circumstances.
RISK ESTIMATION
The process used to assign values to the probability of occurrence of harm and the severity of that harm. The probability or assuming that is will cause danger or harm to the organization.
RISK EVALUATION
The process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.
RISK ASSESSMENT
An overall process comprising a risk analysis and a risk evaluation. Assessment of all the risk and documentation for further process.
RISK CONTROL
The process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels. In this case, risk can be estimated and as per the estimation risk can be controlled.
RESIDUAL RISK
Risks remaining after risk control measures have been taken.
This risk management is a standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher-level regulation and other quality management system standards such asISO 13485. Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and management, and also specifies a procedure for review and monitoring during production and post-production. We are leading medical device Consultant service provider forMedical Device manufacturers dealing with disposable implant & syringe, surgical Instrument, Orthopedic Implantsetc.