Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook Instagram
Call Us Now:
+44 2080667260 sales@omcmedical.com

Articles

Home
Blog Standard
Page 11
november newsletter
28Nov 2024
News admin

November Newsletter 2024 – Japanese

We look forward to sharing the latest updates and insights in our November Newsletter 2024 – Japanese. What’s inside in November Newsletter 2024 – Japanese? 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for November 2024 Please read below for more information. November Newsletter Japanese 2024...
Read More
28Nov 2024
News admin

November Newsletter 2024 – Korean

We look forward to sharing the latest updates and insights in our November Newsletter 2024 – Korean. What’s inside in November Newsletter 2024 – Korean? 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for November 2024 Please read below for more information. November Newsletter Korean 2024...
Read More
november newsletter 2024
27Nov 2024
News admin

November Newsletter 2024

We look forward to sharing the latest updates and insights in our November Newsletter 2024. What’s inside in November Newsletter 2024? 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for October 2024 Please read below for more information. November Newsletter 2024...
Read More
october newsletter
04Nov 2024
News admin

October Newsletter 2024 – Japanese

We look forward to sharing the latest updates and insights in our October Newsletter 2024 – Japanese. What’s inside in October Newsletter 2024? 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for October 2024 Please read below for more information. October Newsletter Japanese 2024...
Read More
october newsletter
04Nov 2024
News admin

October Newsletter 2024 – Simplified Chinese

We look forward to sharing the latest updates and insights in our October Newsletter 2024 – Simplified Chinese. What’s inside!! 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for October 2024 Please read below for more information. October Newsletter Simplified Chinese...
Read More
october newsletter
04Nov 2024
News admin

October Newsletter 2024 – Traditional Chinese

We look forward to sharing the latest updates and insights in our October Newsletter 2024 – Traditional Chinese. What’s inside!! 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for October 2024 Please read below for more information. October Newsletter Traditional Chinese...
Read More
04Nov 2024
News admin

October Newsletter 2024 – Korean

We look forward to sharing the latest updates and insights in our October Newsletter 2024 – Korean. What’s inside in October Newsletter 2024? 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for October 2024 Please read below for more information. October Newsletter Korean 2024...
Read More
october newsletter
29Oct 2024
News admin

October Newsletter 2024

We look forward to sharing the latest updates and insights in our October Newsletter 2024. What’s inside in October Newsletter 2024? 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for October 2024 Please read below for more information. October Newsletter 2024...
Read More
28Oct 2024
EU MDR, Regulations Cubicdesignz

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...
Read More
28Oct 2024
EU, EU MDR, Regulations Cubicdesignz

Article 61 Clinical Evaluation in the EU MDR

Article 61 Clinical Evaluation The MDR reinforces the clinical data and evaluation process (article 61 and Annex XIV), and the manufacturer must confirm the device’s conformity to fundamental health and safety requirements using reliable clinical data and evaluation. The clinical evaluation establishes the device’s safety and capacity to fulfil its intended function. It also evaluates adverse side effects and determines whether the benefit-risk ratio is acceptable. Manufacturers must...
Read More

Enquiry Now

    This will close in 0 seconds