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Services 

This is a Non- complete list, contact us for more information

Moc Audit

 
  • Do you want to prepare for FDA, Notified body or Competent Authority inspections? or just check compliance status

  • Then we are the right partner!


Quality systems

  • We can help you with all aspects of QSR, ISO 9001, ISO 13485 and ISO 14001. we do parts or complete projects

Regulatory 

  • Need market access! We can do or assist with submissions in all key markets in the world. Post market and strategies

Strategy

 
  • We can help with all aspects in submission and quality strategies to ensure sustainable market access for your products
  • Dont get behind your competition due to poor planning. Start now!

Training

 
  • We can train your organization in all areas we work. Standards, QSR, MDD/MDR are just a few examples


Labelling & Promotion

  • Avoid a warning letter or sales stop due to poor controls in this area

Authority handling

  • Got a letter from FDA or LV, better contact us to get advice on how to handle this!

Other

 
  • Advisory and guidance in projects or permanently, interim handling and internal audits are other common services

New in Europe or want to change? we can be your

EU representative

Address:

Högåsvägen 125                    
SE-741 41 Knivsta
Sweden


Contact:

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