为贵公司确定PRRC大多数important requirement that applies to the European Union and is a core area of responsibility for a person or persons under the Medical device regulation, or In vitro device regulation . The directive to appoint the PRRC also depends on the size of the organization. This …
Medical Tubing is used for fluid management and drainage as well as with anesthesiology and respiratory equipment, IVs, catheters, peristaltic pumps, and bio-pharmaceutical laboratory equipment. What sets Medical Tubing apart from other types of tubing is its designation for medical applications. This designation typically comes through standards or certifications which dictate material and specification requirements …
Covid 19抗原检测组件和其他体外成岩作用ostic devices (IVDs) are FDA-regulated products that require FDA and Customs and Border Protection (CBP) clearance when imported into the US. The FDA regulates imported medical devices and IVDs. Generally, imported devices must have FDA marketing approval or must be authorized under an approved Investigational Device …
With advancing medical technology, the medical device market is expected to grow over the next several years due to increased health awareness, a growing middle class, and government health initiatives. The medical device registarion process in India is overhauled in 2017 with the publication of the Medical Device Rules. The rules came into force in January …
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 …
The Government of Tamil Nadu has been taking several proactive intiatives to combat the COVID-19 pandemic. The second wave of COVID-19 has created a severe shortage of medical oxygen and equipments that is vital for the treatment of critically ill positive person. Expert opinion indicate the possibility of third wave in the near future. The …
Incentive package for Medical Device ManufacturersRead More »
The European Authorized Representative for medical devices is assigned a pivotal role in the CE Marking process. If you don’t have one, you can simply not sell your products within the European Union. The European legislation stipulates the role of a European Authorized Representative Authorized Representative for medical devices, also known as EU Auth. Rep., …
Emerging Medical Device Manufacturers is expected to grow by leaps and bounds owing to the rising aging population, increasing health concerns, and sky-rocketing health care costs. As a result, medical device manufacturers are undertaking new product development projects at breakneck speed, especially in the emerging markets. Emerging companies face unique challenges. Those who are at …
In vitro diagnostics for COVID-19 testing has come to demand due to the spread of the deadly virus. The demand for molecular testing, regarded as the gold standard for diagnosing infectious disease, has exploded. While the disease remains uncontained, such demand is likely to keep growing. Meanwhile, the rush to meet it has already driven four …
The Person Responsible for Regulatory Compliance is one of the new requirement of the EU MDR European Medical Device Regulation and In-Vitro Diagnostic Regulation 2017/745 and 2017/746. As the European Union’s (EU) Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR) continue to evolve, one requirement is getting a lot of attention – …
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