CDSCO will be the relevant licensing authority who will approve the packages for Nebulizers manufacturing process in India. The manufacturer needs to use it for CDSCO manufacturing license and our crew will let you whole the licensing system. The producer of this merchandise should comply with the protection and efficacy foremost as consistent with theContinue reading “To Start Nebulizer Manufacturing Unit in India”
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Medical Device Registration in India
Medical Device Registration process in India before manufacturers of certain medical devices can sell within India they need to be in compliance with India’s medical device regulations. Indian authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. Previously, the medical devices manufacturers were free to sell their productsContinue reading “Medical Device Registration in India”
IV Set Manufacturing
IV Set Manufacturing Medical devices assume a huge function in the conclusion, therapy, and checking of a few ailments. Medical clinic gear is carefully intended to keep up thorough wellbeing norms to guarantee the most extreme prosperity of patients. Manufacturer while setting up the manufacturing plant in India need to follow CDSCO registration process. For theContinue reading “IV Set Manufacturing”
Amendment to EN ISO 134852016
Implementing and maintaining a strong quality management system (QMS) for your medical devices, products, and services is critical to the success of your company. Your QMS’s EN ISO 13485 certification displays your dedication to working at a worldwide level. As ISO 13485 medical device consultant we assist our clients in creation of documents for the ISO 13485 certification.Continue reading “Amendment to EN ISO 134852016”
Surgical bandage manufacturing plant
Surgical bandage manufacturing plant can be initiated on a small scale with moderate capital investment. The demand for Surgical Bandage is found all throughout the year. The surgical bandage is the products manufactured from white bleached cotton gauge cloth of suitable quality.Surgical bandage manufacturing plant does a roll form of 3 to 4 meters in length. With theContinue reading “Surgical bandage manufacturing plant”
Is DHF ( Design History File ) required for class I Device?
The Design History file should contain all of the documentation created during the product development phase of your medical device. Following are design controls process which will help you understand what documents are required for DHF. Each step of design control processes generates its own documentation. Design and development planning – D& D planning contains design plan document. Continue reading “Is DHF ( Design History File ) required for class I Device?”
3 Most Important Questions for CE Marking & Requirement of QMS
CE Marking & Requirement of QMS The CE marking indicates that the product you’re holding has been evaluated and certified to fulfil European Economic Area safety, health, and environmental regulations (EEA). The European Economic Area (EEA) consists of the countries that make up the European Union (EU), as well as a few other European countries that areContinue reading “3 Most Important Questions for CE Marking & Requirement of QMS”
Validation Master Plan for Medical device
A master validation plan (MVP) is without a doubt a plan on your system and system validation activities. all of the gadget, procedures, and software program requiring validation have to be covered within the MVP. The plan need to reference the relevant protocol and document for every item in the plan. If there are revalidationContinue reading “Validation Master Plan for Medical device”
What is an example of a combination product?
Examples of co-packaged aggregate products : One example of a co-packaged combination product is an inhaler with filled drug cartridge, which mixes components, an inhaler tool and a drug, right into a unmarried container. Drug with transport mechanism, i.e. nebulizer, inhaler, dropper or syringe convenience kits i.e., first useful resource kits or surgical treatment kits Continue reading “What is an example of a combination product?”
Surgical instruments manufacturing
Surgical instruments manufacturing is done by ONE-piece forging. Surgical instruments are usually made from carbon steel, stainless steel, aluminum, or titanium, and are available in a range of sizes. Surgical instruments are specifically designed tools that are used to assist the health care professionals carry out their specific actions during an operation. For Surgical instruments manufacturing there areContinue reading “Surgical instruments manufacturing”