Medical Device Registration in Egypt: An Overview Medical device registration is a crucial step for manufacturers and distributors to gain market access in Egypt. This process ensures that medical devices meet the necessary safety, quality, and efficacy standards set by the Egyptian regulatory authority(EDA). By registering medical devices, companies demonstrate their compliance with the regulations […]
Medical Device Registration Egypt Read More »
Medical device market growth: The Medical device market looks positive and shows steady growth. Be a part of huge and growing medical device market. The medical device market has been encountering remarkable development throughout the course of recent years. Be that as it may, very much like in some other industry, it is additionally confronted
Top challenges & opportunities for medical device market Read More »
Active Implantable Medical Device (AIMD): Transforming Healthcare with Innovation An active implantable medical device (AIMD) is a type of medical device that is designed to be implanted into the body for a long period of time. It uses electrical energy or a power source other than what is generated by the human body to perform
Active Implantable Medical Devices Read More »
UKCA marking for medical devices. The UK medical devices, are regulated by the Medicine and Healthcare product Regulatory Agency (MHRA). If a medical device manufacturer wants to place their product in Great Britain then they need to have UKCA marking meaning UK product marking. UKCA stands for UK Conformity Assessed, UKCA marking is a substitute
UKCA marking for medical devices Read More »
ISO 11137 – Gamma Sterilization Validation: An Introduction Sterilization is a critical step in ensuring the safety of medical devices before they reach patients. Among various techniques, gamma irradiation stands out, governed by ISO 11137 standards. This method effectively eliminates microorganisms, safeguarding against infection risks. Manufacturers must adhere to rigorous sterilization protocols to uphold patient
ISO 11137: Guidelines for Gamma Sterilization Validation Read More »
What Is FDA Registration and FDA Review Process for 510k? FDA Registration FDA Registration mandated by the United States Food and Drug Administration responsible for protecting public health from various consumer products such as Drugs, Medical devices, Food and cosmetics. The FDA 510(k) registration process involves preparing documentation, demonstrating a device’s similarity to an already
FDA Review Process for 510k Medical Device Submissions Read More »
Medical devices affect the lives of their users, either directly or indirectly. The necessity to understand the quality control process for medical devices stems from manufacturers’ desire to ensure the medical devices’ effectiveness. The primary goal of any medical device is to enhance the lives of its users. But what happens if a product fails
Quality Control Process for Medical Devices Read More »
Risk Management in EN ISO 14971 2019 Overview: Two years ago, EN ISO 14971 2019 Medical Devices – Application of Risk Management to Medical Devices was released. Harmonized Standard EN ISO 14971 2019 has already superseded the earlier standard EN ISO 14971:2012, which only harmonized three directives: MDD, AIMDD, and IVDD. EN ISO 14971:2012’s Z
Risk Management In EN ISO 14971 2019 Read More »
Introduction: For the medical device manufacturer it is important to understand the role of EU MDR economic operator .These operators are also referred with the acronym MAID. The role of economic operator is tied to legal liability so one should understand how they fit in economic operator framework. Who Are EU MDR Economic Operators? Economic
EU MDR Economic Operator & EU Authorized Representative Read More »
Medical Device Registration in Australia: An Overview Medical Devices and In-Vitro Diagnostics are overseen by the Therapeutic Goods Administration (TGA), a division of the Australian Government’s Department of Health. Before any medical device can be supplied in Australia, the device must be included in the Australian Register of Therapeutic Goods (ARTG), which is regulated by
Medical Device Registration in Australia Read More »
