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 types of products will be up classified. That might lead to that you need a Notified body or change notified body. Many software products will be reclassified as an example
There will be more stringent requirements on clinical data both for pre CE marking and post market follow up. No grandfathering of products will be allowed.
We have already now start to see that companies have difficulties to recruit people they need, and this before most companies have started to even think about MDR. make sure you do not loose key people!