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News July 13, 2024 Cubicdesignz Comments: 0

November Newsletter

EUROPEAN UNION (EU) EU guidance on reference laboratories for IVD medical devices | 30 November 2022 EU Commission has published new guidance for candidate reference laboratories in the In vitro diagnostic medical devices field. The document guides laboratories planning to apply in any of the EU Member states. The key topics included are as follows: Notified Bodies under MDR and IVDR | 21 November 2022 The 35th Notified Body, SGS Fimko Ltd, for Regulation (EU) 2017/745 on Medical Devices (MDR),...
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13Jul 2024
News Cubicdesignz Comments: 0

February Newsletter

EUROPEAN UNION (EU) MDCG guidance on vigilance terms and concepts of EU MDR | 14 February 2023 The MDCG 2023-3 guidance document clarifies some of the essential terms and concepts in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). The topics covered in the guidance document are as follows: MDCG Guidance on Classification of IVD under IVDR | 10 February 2023 The MDCG 2020-16 rev.2 guidance addresses the requirement for the classification of IVDs under the classi...
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News July 13, 2024 Cubicdesignz Comments: 0

March Newsletter 2023

EUROPEAN UNION (EU) Guidance on MDR transitional period extension | 28 March 2023 The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out, in...
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News July 13, 2024 Cubicdesignz Comments: 0

April Newsletter 2023

Germany Database for In vitro diagnostics Medical Devices notification | 25 April 2023 In Vitro Diagnostic Medical Devices Notifications includes notifications on the first placing of in vitro diagnostics on the market (according to § 25 MPG – Act on Medical Devices). The database is part of the German database-supported medical devices information and database system. Included therein is mainly administrative data and further data relevant to the notification. Finland Electronic submissi...
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News July 13, 2024 Cubicdesignz Comments: 0

May Newsletter 2023

EUROPEAN UNION (EU) Updated MHRA guidance on significant changes under MDR | 12 May 2023 The guidance document MDCG 2020-3 Rev.1 is intended to clarify the concept of ‘significant changes in the design and intended purpose’ under Article 120(3c), point (b) MDR. It concerns manufacturers of legacy devices. This guidance document does not elaborate on the process for manufacturers’ submission and notified bodies’ assessment of changes to the approved design or substantial changes to the ap...
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News July 13, 2024 Cubicdesignz Comments: 0

June Newsletter 2023

EUROPEAN UNION Implementation of Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose | 21 June 2023 The deadlines for Annex XVI products mentioned in Implementing Regulation (EU) 2022/2346 has been extended in the Implementing Regulation (EU) 2023/1194 of 20 June 2023. To find out more about the extended deadlines, click here. Addendum to MDCG Position Paper on the application of Article 97 | 30 June 2023 The position paper MDCG 2022-18 was publi...
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13Jul 2024
Job role Cubicdesignz Comments: 0

Associate and Intern Role – Regulatory Affairs

We are inviting applications for Associate Role – Regulatory Affairs No. of positions: 05 Experience Level Entry & Mid-Level Mid-Level: 2-5 years of experienceIn this role, you will be expected to have the following attributes:• Work on deadlines• Highly professional• Excellent Microsoft Outlook, Excel, Word, and PPT skills• Basic knowledge of medical devices• English speaking, writing, and listening skills are highly desired• Attention to details• Individual contributor...
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13Jul 2024
IVD Cubicdesignz Comments: 0

Labelling and IFU requirements of the New EU IVDR

Information for use (IFU) and labels must be provided with every In-Vitro diagnostic medical device, containing information to identify the device, its manufacturer and any relevant safety and performance information for the user or any other person.     Such information may be found on the device itself, in the packaging, or in the user instructions (IFU), and if the manufacturer has a website, it must be made available and maintained up to date on the website. Updates in Labelli...
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12Jul 2024
General Information Cubicdesignz Comments: 0

Product Liability Insurance for Medical devices

Medical devices are subject to product defects. These product defects arise due to design, manufacturing or even a failed instruction for use of a product. These defects can cause risks to patients, who in turn can sue the manufacturer for the damages caused. As medical device manufacturers, it is imperative to choose insurance that best covers themselves as well as their affiliates. Product liability was brought in place to ensure that potentially unsafe products are discouraged from being plac...
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12Jul 2024
General Information Cubicdesignz Comments: 0

Establish a Medical Device Startup Company

Introduction: Medical device startups play an essential role in revolutionizing patient care and improving quality of life. If you share our passion for innovation, starting a medical device company could prove rewarding yet challenging – this article offers comprehensive guidance to help get one started. Tips to start a Medical Device Startup Company 1. Brainstorm an Engaging Idea: Every successful medical device startup begins with an original idea. Start by researching the healthcare in...
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