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Consulting - We make your medical device or system ready for market. Mediteq
 
Mediteq can guide you through the regulatory process, or take on an operational role, where we take care of everything in the project; from planning, to execution and closing the project on time.

It is you, as our customer, who decides to what extent Mediteq should be involved and how much of the work you would like to do yourself.

Regardless, Mediteq will help you reach your goal!
Mediteq assists you with;
  • CE-marking according to - MDR, IVDR, PPE
  • FDA applications e.g. 510k or presubmissions
  • Product authorization / registration in other markets - Canada, Australia, Asia
  • Implementation and certification of quality management system certificates - create routines that works
  • 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 are looking for
  • Business analysis: what is required 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
  • PRRC - Person Responsible for Regulatory Compliance
  • Review of technical documentation to CE marking with or without the requirement to have a Notified Body
  • GAP analysis for MDR or IVDR
  • Plan and review clinical evaluation/ review clinical studies or plans
 
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Mediteq Info
Mediteq Svenkebo AB
Kanalstråket 1, SE-433 76 Jonsered
+46 31 774 25 00 contact@mediteq.se