Market access strategy, Handling of authorities and compliance projects.
How should you think when you organize the Quality and regulatory affairs organization, global vs local to get out most of it.
We can assist and/or drive regulatory affairs related activities around the world. A few examples are product submissions, post market surveillance, Authorized representative, labeling and promotion control.
We do most kind of quality related activities covering FDA´s QSR and quality standards such as
ISO 13485, ISO 9001 and environmental standard ISO 14001.
We have extensive experience in:
- All product classes
- 10 Notified Bodies
- EU task forces
- Authorised representative
- Technical files
We have, in the nordic region, unprecedented experience in handling FDA issues, untitled letters, 483´s and 510(k) submissons.
FDA Moc audits.
We have long experience working in upper management positions driving company strategies and implementing management systems globally
Several type of products will be reclassified upwards that might lead to that you need a Notified body! many software products are in this category!
Requirements on clinical data will be strenghten even further than MEDDEV 2.7.1 rev 4. This applies both on pre and post market. No grandfathering are allowed why you need to look into this.
Will your existing Notified body exist or do you need one for the first time! This can be a tricky situation and most companies have issues with this already. Start early, use help from ecperienced people to open doors!
number of tasks are increasing and the competition of people get worse. Industy, Notified Bodies and authorities are all fighting about the same people! Ensure your key people stays the coming 3 years!