ISO 13485 is a QMS standard necessary for medical device manufacturing. let’s discuss in brief the ISO 13485 certification process and FAQs related to them. As an ISO 13485 certification consultant, we guide manufacturers to get ISO 13485 certification. What is ISO 13485? ISO 13485 is a standard company that is either involved in manufacturing or […]
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Importance of ppe in healthcare COVID-19 pandemic has taken a critical health and financial cost for the population. As we became familiar with the sickness and how it spreads, reports began rising of healthcare workers getting contaminated. We were additionally shown the importance of PPE in healthcare in safe-guarding our frontline healthcare workers. A PPE
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The successful PPE storage solutions for clinical personals can be accomplished by the utilization of PPE coordinators. Individual security hardware coordinators hold an enormous measure of different supplies and spare truly necessary room by putting away the gear in space-productive compartments. Personal Protective Equipment protective garments, caps, goggles, or different pieces of clothing or equipment
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Introduction of Quality and Regulatory Affairs of Medical Device: Quality and Regulatory Affairs is a profession that came from governments’ desire to protect public health by ensuring the security and adequacy of products in areas such as pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, beauty care products, and complementary medicines. Medical equipment, pharmaceuticals, and clinical
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Medical Device development Medical device development is the process of designing, creating, and bringing to market a device intended for medical purposes. It involves activities such as concept generation, design, prototyping, testing, regulatory approval, and manufacturing. Medical device development seems to be a complex process with rigid requirements for FDA approval. Medical device professionals with significant expertise in the field of devices can comprehend and divulge rule pertaining to such goods to
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Integrate Usability into medical devices for a better risk based testing process that includes testing how easy simple and safe a medical device is. It is a prerequisite to test convenience on medical devices to guarantee that the devices itself fulfils government guidelines. Factors that effect to integrate usability into medical devices or an products
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Introduction of Quality Control and Quality Assurance: Quality control and quality assurance are phrases that are commonly used interchangeably. Despite their similarities, the two concepts have distinct differences. Quality control and assurance are a combination of measuring product quality and ensuring products and services fulfill consumer expectations. Quality assurance is process-oriented and focuses on deformity
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Why Is the Regulatory Compliance Strategy for Medical Devices Important? Medical device manufacturers who fail to portray regulatory compliance issues from the start of the process are frequently greeted with unexpected outcomes. activities to achieve regulatory compliance after the product development process has been completed can be a substantially more complex operation, resulting in additional
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Disposable Medical Device Manufacturing – An Overview Disposable medical device manufacturing focuses on producing single-use medical instruments and apparatus designed for one-time use. These devices are commonly utilized in hospitals and healthcare settings and are disposed of after use. According to the FDA, a disposable medical device is intended by the manufacturer for use on
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Add Your Heading Text Here The requirements for MDR classification for medical devices are nearly identical to those in the current Medical Devices Directive (MDD). The EU MDR is shaking up the medical device business, and the order regulations have not been left spotless. The MDR decides on the device’s congruity assessment course. While the
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