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Quality &
Regulatory 
Consultants

Your Quality and Regulatory Affairs partner to ensure:

Sustainable and predictable market access

Mobirise

Company Strategies

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.

Mobirise



Regulatory Affairs

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. 

Mobirise



Management systems

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.

Our experience

We provide competence and "know how" in all areas we work!

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

Have you started to think about the new MDR, A few key things to consider!

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!

Mobirise


CONTACT FORM

If you want us to contact you please fill in the form and we will come back to you. 

Address:

Högåsvägen 125                    
SE-741 41 Knivsta
Sweden


Contact:

Email: info@lowendahl.eu                    
Phone: +46 (0) 722 313355            









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