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
should be involved and how much of the work you would like to do yourself.
will help you reach your goal!
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 Svenkebo AB
Kanalstråket 1, SE-433 76 Jonsered
+46 31 774 25 00