The Medical Device Single Audit Program (MDSAP) enables a single regulatory audit of a medical device manufacturer’s quality management system, meeting the standards of numerous regulatory jurisdictions. Here are some MDSAP FAQ that may help you with your questions. Some Important MDSAP FAQs: We Sell in Canada Is MDSAP Required? To sell any Class II, […]
Plastic injection molding has transformed the way medical devices are made. It’s a cost-effective, exact manufacturing process that allows for the production of complex components while meeting the strictest industry standards. This method ensures medical-grade parts with exceptional durability, chemical resistance, and high tensile strength while maintaining the necessary levels of cleanliness and sterilization. Why
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For Classifying a Class III Medical Device the FDA established certain regulatory controls in the form of general controls and special controls. The classification of medical devices (Class I, Class II or Class III) will determine the type of regulatory controls the FDA imposes to ensure the device’s safety and effectiveness before being placed into
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Benefit-Risk Analysis in Medical Devices ISO 14971 requires medical device manufacturers to conduct a benefit-risk analysis of their devices as part of the certification process. As a result, this page educates readers on what BRA is, how to assess the advantages and hazards of a medical device, and which guidelines to follow. Benefit-Risk Analysis Benefit-risk
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Preventing spread of infection relies on effective use of Disposable Medical Gowns from the coronavirus disease 2019 (COVID-19). With increasing awareness about the highly communicable bacteria and viruses, medical professionals and associations are making it mandatory to use protective Disposable Medical Gowns to barrier the spreading of various diseases like SARS, HIV, hepatitis, etc. These
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PPE kit business in discipline for quality standards: Since the time the Covid-19 wave hit Indian subcontinent, the dread in a flash prompted an extreme lack of hand sanitizers, surgical masks, and PPE kits. This was in April 2020 when India had no PPE kits manufacturing facility. From that point to be the second biggest
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Remote Patient Monitoring Devices has emerged as the next significant challenge for virtual healthcare and that challenge is creating significant opportunities for many companies largely outside of the traditional healthcare technology marketplace. In an age when nearly everyone is digitally connected in some way – even many senior citizens, who are often characterized as technophobic
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Medical Tubing Manufacturing: Precision, Safety & Reliability Medical tubing isn’t just any tubing—it’s a lifeline in healthcare, used in everything from IVs and catheters to respiratory equipment and lab applications. Designed for fluid management, drainage, and drug delivery, it meets strict safety and quality standards to ensure reliability in patient care. With carefully selected materials
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Impact of COVID-19 on medical devices growth, has been expontential. Hospitals are struggling as the disease spreads faster than companies can produce masks, ventilators, and tests. As of early May 2020, over 4.7 million people have been confirmed to be infected with the SARS-CoV-2 coronavirus, and governments are scrambling to contain its spread. The high R0
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CT scan machines have revolutionized medical imaging, providing clear, detailed 3D views of the body for accurate diagnosis and treatment. Unlike traditional X-rays, CT scanners capture multiple images from different angles, helping doctors detect complex conditions with precision. At Operon Strategist, we guide manufacturers through every step of CT scan equipment manufacturing, from regulatory approvals
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