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Generating innovation. For better living and health.

Oslo Medtech Quality Assessment Regulations Forum (QA-Reg Forum)

The objective of Oslo Medtech QA-Reg Forum
The objective of Oslo Medtech QA-Reg Forum is to enhance the competence of regulatory issues of different markets, and be a networking arena for the members of Oslo Medtech, focusing on presenting and discussing quality- and regulatory requirements, classification and approval procedures in different markets/continents.

Who can attend?
Oslo Medtech QA-Reg Forum is a forum and meeting place for paying members of Oslo Medtech. Companies that consider membership, and would like to attend the seminar to get to know the QA-Reg Forum and Oslo Medtech as a part of their membership-decision, are also welcome to attend. For questions and membership-info – contact the CEO of Oslo Medtech, Kathrine Myhre kathrine.myhre@oslomedtech.no

Access to the presentations
Access to the presentations given by the experts are available for Oslo Medtech members at this site. Password is required. Please contact cecilie.nordbo@oslomedtech.no if you have problems with registering as a member.

The QA-Reg Project group consists of the following partners:

    

Haflan Resources
Haflan Resources provides consultancy and expertise within the area of quality assurance and regulatory affairs for medical device and IVD. Haflan Resources advices and supports medical device manufacturers in their process of establish, implement and maintain quality management systems. Other services include activities concerning applications for and preservation of registrations, and complete required audits.      

Contact:    Anne-Karine Haflan, Senior consultant
Cell:   +47 97683900
Mail:   nine.haflan@gmail.com
Web:    
 
 

    
Nemko
Nemko Group offers testing, inspection and certification services concerning products and systems on a worldwide basis, being represented in more than 23 locations in 4 continents. Nemko is Notified Body for the Medical Device Directive and accredited for ISO 13485 certification. Nemko test laboratories are testing active medical devices in Europe, America and Asia.   
Contact:    Steinar Megaard, Senior Vice President
Phone:    +47 90048046
Mail:    steinar.megaard@nemko.com
Web:    www.nemko.com
 
 

  
Det Norske Veritas
DNV is an independent and autonomous foundation working to safeguard life, property and the environment. We are a knowledge-based company and our prime assets are the creativity, knowledge and expertise of our people. As a worldleading certification body and a global provider of solutions for managing risk, we work to help our customers safely and responsibility improve performance.
    
Contact:   Cecilie Gudesen Torp, Service Responsible Medical devices
Phone:   +47 67579748
Mail:   cecilie.gudesen.torp@dnv.com 
Web:   www.dnv.com
 
 

 

 

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