Consulting

“All men by nature tend to knowledge.” Aristotel

I provide you professional regulatory advice in the field of medical devices.
I advise economic operators in the field of medical devices and adapt my services to the individual requirements and needs of clients.

I offer services such as:

  • Review and coordination in the preparation of relevant of QMS documentation
  • Make recommendations for improvements and regulation of areas necessary for compliance with MDR / IVDR
  • advising on the implementation of the assessment by the notified
  • I advise on the registration of activities
  • I advise on the registration of a medical device
  • I advise on the preparation of post market surveillance (PMS)for a medical device
  • I advise on setting up a vigilance system
  • Depending on your needs, I prepare and carry out internal training for you individually.

I offer the service of quick searching for a suitable notified body in one-step for manufacturers of medical devices and in vitro diagnostic devices.

I provide services for manufacturers, authorized representatives, importers, distributors, notified bodies and other institutions that operate and deal with topics in the field of medical devices.

I communicate with the competent authorities on your behalf. I offer you support in tailor-made training from theory to practice and I carry out internal assessments for you independently and impartially.

I follow all news from the field, which is constantly evolving and offers innovative solutions.

I advise on strategic projects related to quality and regulatory matters for medical devices.

Through cooperation in the network, I help you find the right distributor in the EU member states.

Do not hesitate to contact me to get the right solutions for your challenges.

Do you ask questions about the new legislation such as…

  1. How to identify new MDR and IVDR requirements?
  2. How should I implement the new legislative requirements and carry out the conformity assessment procedure?
  3. Do I meet all the obligations, what am I still missing?
  4. How do I register my activities?
  5. How do I register a medical device and check that it is still in the same class?
  6. How to update and prepare technical documentation?
  7. Does the clinical evaluation prove clinical equivalence; do I need to conduct a clinical trial?
  8. Is the post market surveillance (PMS) of the medical device appropriate, including the PMCF?
  9. Do I manage all documents of external origin (corrections of regulations, MDCG documents, implementing and delegated acts …)?
  10. What information will you need to enter in Eudamed?

Do you know the answers?

Do not hesitate to contact me to get the right solutions for your challenges.

The company

MedDev Rešitve, Marcia Elena Podboršek s.p.

Dragomelj 78A, 1230 Domžale, Slovenia

Phone

00386 41 556 499

Email

info@medical-device.si
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