Category Archives: Uncategorized

Safety and quality are non-negotiable in the medical device industry. Risk management at early stage, Intellectual Property protection, design quality control, prioritizing, understanding and buying the insurance helps in managing the business risk as a medical device company. Medical device risk management for safety makes it easy to understand the risk associated and provides a solution.  To originateContinue reading “Medical Device Risk Management As Non-Negotiables for Managing Business Risk”

Dental Implants Manufacturing Dental implants additionally allude as endosseous implants or fixtures. It is a careful part that is utilized that associates with the bone of the jaw or skull to help a dental prosthesis, for example, a crown, extension, and denture, facial prosthesis or to go about as an orthodontic anchor. What are dental implants?Continue reading “Dental Implants Manufacturing”

Disposable Medical device manufacturing or single-use medical devices are medical devices or any medical apparatus or instrument which has the capacity of being used only for once or which has one time use. Disposable devices are used in hospital or healthcare sectors and then after used is been disposed of. The FDA defines that this deviceContinue reading “Disposable Medical Device Manufacturing”

EU MDR compliance for Legacy Devices Legacy devices are the medical devices, active implantable medical devices and in vitro diagnostic devices that are placed in the market with valid certificates issued from Medical Devices Directive (MDD) or Active Implantable Medical Device (AIMD). The valid CE (Conformité Européenne) marking certificates are issued according to Directive 93/42/EEC,Continue reading “EU MDR compliance for Legacy Devices”

Saudi Arabia SFDA Guidance on UDI A wide range of medical devices are available in the market. The rising concerns related to medical devices like patients’ safety and supply chain management has forced the introduction of a single, unique, globally harmonized identification system for every device. UNIQUE IDENTIFICATION IDENTIFIER The US FDA has established theContinue reading “Extends Deadlines for Saudi Arabia SFDA Guidance on UDI”

Product Development  Medical Devices The medical device sector has a remarkable impact on the healthcare industry and is expanding its role in the global economy. It is significantly evolving over the span of years.  Advancement in scientific knowledge and engineering technology has accelerated the innovation in medical devices. Medical device technology is interdisciplinary and individualsContinue reading “Product Development Medical Devices”

What is FDA 510 k Clearance? Every device manufacturer who wish to trade in the US market for the classified medical device Class I, II, and III. Premarket approval application (PMA) is not necessary if those are meant to human use. But must submit FDA 510 k unless the device is exempt from 510 k necessity ofContinue reading “FDA 510 k medical device approval process – operonstrategist”

FDA medical device approval If you are looking for FDA medical device approval process for your medicinal device then you are in the right place.Medical devices, from ideation to post-launch assessment, are directed in the United States by the U.S. Food and Drug Administration (FDA) under the Medical Device Regulation Act of 1976 an ensuingContinue reading “FDA medical device approval process step-by-step guide”

The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI. Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and Drugs and Cosmetics runs under 1945.CDSCO classification for medical devices has a set of risk classifications for numerousContinue reading “CDSCO Classification for medical devices”

Dental implants additionally allude as endogenous implants or fixtures. It is a careful part that is utilized that associates with the bone of the jaw or skull to help a dental prosthesis, for example, a crown, extension, and denture, facial prosthesis or to go about as an orthodontic anchor.Materials used in Dental Implants ManufacturingImplant MaterialMetals1. Titanium2.TitaniumContinue reading “Dental Implants Manufacturing”