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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 Authorized representative

Address:

Högåsvägen 125                    
SE-741 41 Knivsta
Sweden


Contact:

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