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Cubicdesignz

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Author: Cubicdesignz
Page 8
12Jul 2024
EU, EU MDR Cubicdesignz Comments: 0

Staying Vigilant: Best Practices for Post-Market Surveillance under EU MDR

As medical device manufacturers navigate the landscape of post-market surveillance (PMS) under the European Medical Device Regulation (EU MDR), maintaining vigilance and adherence to best practices is crucial. Effective PMS not only ensures ongoing product safety and efficacy but also facilitates compliance with regulatory requirements. Top 7 Key Strategies for optimizing Post-Market Surveillance Here, we outline key strategies for optimizing post-market surveillance in alignment with EU MDR sta...
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12Jul 2024
EU, General Information Cubicdesignz Comments: 0

Ensuring Compliance and Quality: The Role of CE Marking in Safeguarding Patient Safety

The CE marking signifies a medical device’s adherence to stringent European Union (EU) safety regulations. This compliance process, known as CE marking compliance for patient safety, is critical in ensuring the quality and effectiveness of medical devices. By mandating rigorous assessments, it directly impacts patient safety. Manufacturers must demonstrate their devices meet essential safety and performance requirements, minimizing risks associated with malfunction, biocompatibility issues...
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12Jul 2024
EU, General Information Cubicdesignz Comments: 0

Directive (EU) 2019/904 on the reduction of the Impact of certain Plastic Products on the Environment

Introduction Directive 2019/904 aims to mitigate the environmental and health impacts of specific plastic products, particularly in aquatic environments, while fostering the transition towards a circular economy through innovative and sustainable practices. It encompasses single-use plastic items outlined in the Annex and products made from oxo-degradable plastic and plastic-containing fishing gear. Member States are mandated to implement measures to significantly reduce the consumption of singl...
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News July 12, 2024 Cubicdesignz Comments: 0

MDCG Position Paper on the Implementation of UDI Requirements for Contact Lenses, Spectacle Frames, Spectacle Lenses & Ready Readers 

The Medical Device Coordination Group (MDCG), which was founded in accordance with Article 103 of Regulation (EU) 2017/745, has approved this document. Every Member State is represented on the MDCG, which is presided over by an official from the European Commission.   The document cannot be regarded as representing the official stance of the European Commission because it is not a document from the European Commission. This paper does not contain any legally binding opinions. The only body tha...
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12Jul 2024
Canada Cubicdesignz Comments: 0

Health Canada Medical Device Listing

Health Canada is the regulator of therapeutic products, including medical devices. Health Canada’s Medical Devices Active Licencing Listing (MDALL) contains a list of products that are already in the Canadian medical device market. It also contains the database for products that were previously licensed. This article discusses the various information available on MDALL. Read our article on overview of medical device registration in Canada to understand the various license requirements for diff...
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12Jul 2024
Canada, FDA, USA Cubicdesignz Comments: 0

eSTAR Pilot program by Health Canada & US FDA

eSTAR (electronic Submission Template and Resource) is an initiative launched by the US Food and Drug Administration in February 2020. It is a free, interactive PDF Form that provides assistance to the applicants in preparing the CDRH medical device submission for 510(k)s and De Novos. The content of the form is automated with an automatic verification feature, and the structure is complementary to the internal review and also harmonized with the IMDRF and guided construction for each submission...
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12Jul 2024
EU, Brazil, General Information, India, Swiss, UK, USA Cubicdesignz Comments: 0

Testing Standard Requirements around the World

Medical device testing standard- an overview Medical device testing is a crucial step in manufacturing a product. This mandatory process ensures that the medical device is safe and effective. Testing of medical devices proves that the product complies with the standards and regulations of a country. Moreover, it also sheds light on any product defects. This article discusses the testing requirements and the applicable standards. Medical device testing applies to all medical devices, in-vitro dia...
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05Feb 2024
EU, General Information, Regulations Cubicdesignz Comments: 0

Smart Wearables Regulations in the EU 

The booming technological aspects have constantly challenged regulations established worldwide in the modern century because the regulations either inadequately govern novel technologies, or there always exists a scenario where the devices cannot be categorized within a given regulation. Smart wearables are one of those aspects falling into such debate in recent times. Days are no longer from the fact that these smart wearables may draw strict regulations to be in place. How are these general we...
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05Feb 2024
EU, General Information, Regulations, UK Cubicdesignz Comments: 0

Exceptional Use Medical Devices in the EU and UK

Medical devices conforming with the medical device regulations must have a conformity marking. Medical devices that do not conform may still be placed in the market, provided they apply through the exceptional use devices pathway. This article discusses the exceptional use requirements to be satisfied to gain access to EU and UK markets. In the UK, the UKCA marking displays that the device conforms to UK Medical Device Regulations 2002. Without UKCA marking, the devices can only be placed in the...
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05Feb 2024
EU, Regulations Cubicdesignz Comments: 0

ISO 20417:2021 – Information to be supplied by the Manufacturer

Engineered medical devices are introduced to the market for use in clinical scenarios. From a user’s perspective, the safe and effective usage of a medical device is highly influenced by providing appropriate accompanying information with the device labels and user instructions. An international standard that defines the information to be supplied by the manufacturer of Medical Devices is ISO 20417:2021, with the latest version as ISO 20417:2021. Besides, ISO 15223 stands for requirements that...
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