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Medical devices

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Tag: Medical devices
13Jul 2024
Registrations Cubicdesignz Comments: 0

Iraq Medical Device Registration: KIMADIA Guidelines and Requirements

Navigating Medical Device Registration with Iraq’s Regulatory Authority: KIMADIA Guidelines and Requirements  Regulatory Authority: State Company for Marketing Drugs and Medical Appliances (KIMADIA)  “Kimadia” refers to the Iraqi State Company for Marketing Drugs and Medical Appliances. It is a governmental organization responsible for procuring and distributing pharmaceuticals and medical supplies within Iraq, including through tenders and procurement processes.  When...
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12Jul 2024
General Information Cubicdesignz Comments: 0

Understanding the Key Responsibilities of an Authorized Representative in the Medical Device Industry

In the complex ecosystem of the medical device industry, ensuring compliance with regulatory standards and navigating the path to market access are crucial tasks. Amidst this complexity, one key player stands out: the Authorized Representative (AR). ARs are recognized globally under different titles, including Responsible Person (RP), Agent for Service of Process, Local Agent, Legal Representative (LR), and Designated Contact Point (DCP), Market Authorization Holder (MAH). Their role carries sig...
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12Jul 2024
General Information Cubicdesignz Comments: 0

Navigating Regulatory Requirements: Compliance Essentials for Post-Marketing Surveillance

The medical device industry thrives on innovation, but ensuring patient safety remains paramount. Regulatory compliance, particularly in post-marketing surveillance (PMS), is crucial for safeguarding patients and maintaining market access. This article explores the essentials of navigating regulatory requirements for medical devices, focusing on effective PMS practices. The Importance of Post-Marketing Surveillance Unlike pre-market testing, post-marketing surveillance monitors a device’s...
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12Jul 2024
General Information Cubicdesignz Comments: 0

License Transfer for Medical Device to new Local AR – New Zealand

Medical devices play a crucial role in healthcare by diagnosing, treating, and monitoring various medical conditions. These devices are designed and manufactured by companies that must obtain licenses to sell their products in different markets. When a company wants to transfer the license for a medical device to a new local Authorized Representative (AR) in a different country, such as New Zealand, there are several key steps and considerations that must be taken into account. Transferring the...
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12Jul 2024
General Information Cubicdesignz Comments: 0

License Transfer for Medical Device to New Sponsors from Existing License Holders

License transfer for medical devices is a crucial aspect of the regulatory landscape governing the manufacturing and distribution of medical products. It allows existing license holders to transfer the rights to manufacture and market a specific medical device to a new sponsor or entity. This process is essential for ensuring the continued availability and safety of medical devices in the market. License transfer allows for the continued availability of medical devices in the market, even as own...
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12Jul 2024
EU, FDA, Regulations, USA Cubicdesignz Comments: 0

Cybersecurity for Medical Devices – FDA and EU MDR Perspective

FDA –Food and Drug Administration The revolution in the digital sector has resulted in the Internet of Things (IoT), Software as a Medical Device (SaMD), Internet of Medical Things (IoMT) and other connected devices permeating the healthcare environment, both in hospital and home, has ended up with the possibility of cyberattacks and intrusions against the connected medical devices and the networks to which such a device is connected. Most Medical devices are connected to the Internet, hospita...
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12Jul 2024
EU MDR, Regulations Cubicdesignz Comments: 0

Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023 

Introduction Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have introduced significant changes to the timelines and conditions for placing certain medical devices on the market or putting them into service. This comprehensive analysis explores the key points of these amendments, focusing on the intricate timeline considerations.  Paragraph 3 Amendments Paragraph 3 has undergone crucial revisions, introducing new provisions (3a to 3g) that...
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12Jul 2024
EU MDR, General Information Cubicdesignz Comments: 0

The Role of Notified Bodies in Assessing Clinical Evaluation Reports (CERs) under EU MDR

Clinical evaluation is a continuous procedure that happens at every stage of a medical device’s life cycle. It is typically carried out initially in the course of developing a medical device to determine what data must be produced to gain access to the market. The first CE-marking must include a clinical evaluation, and it must be regularly updated going forward. Clinical evaluation is essential and significant because it guarantees that assessments of the device’s performance and sa...
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12Jul 2024
EU, EU MDR Cubicdesignz Comments: 0

EU MDR Market Surveillance Activities

Market surveillance is the activity carried out by the competent authorities according to Article 93 of MDR 2017/745 to ensure that products on the market comply with the relevant laws and regulations and with the current EU health and safety requirements. Maintaining market security in Europe and promoting consumer safety and business trust is vital. Suppose the medical device poses an unacceptable risk to the health or safety of the patients, users, or other people or any other aspects of the...
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