advises you through the process, or we offer operational services, where we take care of everything in the project; from planning, to execution, to reaching the finish line on time.
It is you, as our customer, who decides to what extend
should be involved and how much of the work you would like to perform yourself.
will help you reach your goal!
assists you with;
FDA clearance, e.g. 510(k)
Product authorization / registration on other markets - Canada, Australia, Asia
Implementation and certification of Quality management system certificates
Internal audits and/or supplier audits; gives you a confirmation that yours, as well as your suppliers procedures and processes work, both in theory and reality
Regulatory analysis; what is required to achieve the product approval you desire
Business analysis; what is required in order for your organization to reach compliance with the regulatory requirements
Acting as additional resource for a single project or approval, or as Quality or Regulatory manager
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Mediteq Svenkebo AB
Kanalstråket 1, SE-433 76 Jonsered
+46 31 774 25 00