The idea is also to provide easy access to high quality and updated information about the developments in this field.

To lead the workgroup, OMT has selected Anne-Karine Haflan, of Haflan Resources. Anne-Karine works as a consultant to the medtech- and pharmaceutical industry, providing consultancy services within project management, regulatory work, quality assurance and GMP. She has more than 20 years of experience from the medtech-, and pharmaceutical industry.

The workgroup meetings will be held at alternate venues provided by the members. In this way we will also provide an opportunity for the participants to get to know each other better. This first meeting was hosted by OMT member Det Norske Veritas (DNV). DNV’s Aud Løken Eiklid gave the meeting’s main talk: “Changes in the European Council Directive on medical equipment, effective from March 2010”. Also on the programme was an introduction to Oslo Medtech and the QA & Regulatory Forum, followed by a roundtable discussion about the plans for the workgroup going forward. You can download Aud Løken Eiklids presentationhere:

The turnout for the meeting was very good. “- This is really promising!” says Kathrine Myhre, Project Leader of OMT. “30 people from 17 companies showed up for our first meeting! I think this shows that QA and Regulatory issues are an important area for the OMT members, and an area where many companies see that they can benefit from sharing their knowledge. These workgroup meetings will be very much an activity for the members – by the members. Our hope is that even more will join us and contribute to the forum - both with their questions and concerns and with their knowledge and experience.“

If you have an idéa for the next meeting in the QA & Reg Forum, or if you have questions regarding QA-Reg issues, please make contact with Oslo Medtech or Anne-Karine Haflan in Haflan Resources; mob +47 976 83 900 / nine.haflan[at]gmail.com