Designing Effective Warnings for Medical Devices
Do you really think Warning signs need to be given attention as few people believe that warnings are USELESS. This are the warning signs which are printed on #medicaldevices only to warn people about the legal protection. Every manufacturer should use this sign as they have been liable for the “failure to warn,” and adding warnings neutralizes this claim. There are many types of warnings that indicate certain protection, some warnings offer some protection against some hazards some of the time. They are one among many possible risk mitigations and not usually a substitute for designing a medical device to be permanent safe. Here are some significance of warning signs, one convention is to give attention to a warning using a signal word. The main options are “DANGER”, “WARNING” and “CAUTION”. The decision of signal word relies upon the probability that somebody could be hurt and the seriousness of the damage. "DAMAGE" demonstrates a hazard that will kill you in the event of exposure to it. "WARNING" indicates that a risk may seriously harm or kill you in the event of exposure to it. And lastly, "CAUTION" indicates a chance of slight to moderate harm.
To get attention on this warning boards it is better to state the hazard (e.g., “High voltage”) or safety objective (“Prevent burns”) and either prohibit a behaviour (e.g., “Do not remove panel”) or encourage safe behaviour (e.g., “Keep hands away”). To get a proper guidance on the #riskmanagement #ISO 14971 we specialize in providing consultancy & regulatory assistance for Medical Device manufacturing plant layout, Clean Room Validation Service and Design Services, compliances, import and exports paperwork to more than 125 countries. Hence, we ensure the hassles of regulatory bodies are expertly taken care off. For further enquiry, Contact Us on, Email-id: info@operonstrategist.com , anilmchaudhari@gmail.com Contact No: +91-8087003428 / 9028043428 Website: www.operonstrategist.com
Kind Regards,
Medical Device Manufacturing Regulatory Consultant: Operon Strategist