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Do you want to prepare for FDA, Notified body or Competent Authority inspections? or just check compliance status
Then we are the right partner!
We can help you with all aspects of QSR,
ISO 9001, ISO 13485 and ISO 14001. we do parts or complete projects
Need market access! We can do or assist with submissions in all key markets in the world. Post market and strategies
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!
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
Got a letter from FDA or LV, better contact us to get advice on how to handle this!
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
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Phone: +46 (0) 722 313355