MDD 2007/47/EC places new requirements on companies in regulated industries that export to the European Community. We’ve put together the following 6 questions to help you determine your state of readiness for the new regulations…
1. Are there any parts of the User Interface (UI) for your products that are not localized for any of your export markets? If so, those now need to be translated.
2. Have you determined the volume that will now need to be translated in your software localization efforts? You could see a substantial increase in budgets, timelines and resources required for future product releases.
3. Do you have a document control system (such as Agile)? If you do not have a document control system you may have a tough time managing the additional translation that will need to be performed.
4. Have you rationalized this additional volume against revenue attained for each of the target countries? Some of them may not justify the additional cost, but you’ll need to communicate that to your sales team.
5. Is engineering ready for the increased volume? In order to accommodate these new localized User Interfaces, your engineering team will now need to create additional software builds for those countries.
6. Have you shifted to electronic distribution of manuals? This is actually one of the few benefits of the new directive.
If the answer to any of these questions is no, then we have a great solution for any of your MDD 2007 concerns. We are offering free demo’s to help show the benefits of Argo’s Regulatory Compliance Platform for companies in the medical device industry. Please contact an Argo Translation Sales Manager to schedule a time for this demo.