Target Groups

LVL Mediphar has a long experience in serving several small start up companies, needing a full service package from quality system start up, regulatory asssistent, production know how, validation, medical writing, STED and DHF redaction,  …
Due to long experience in medical devices, a network of reliable partners and practical hand-on approach, we have always succeeded to achieve clients goals, timelines and expectations. i.e.

  • Implants (IUD – IOL - ….)
  • Extracorporeal circulations devices (dialysis, plasmaferesis, CPBP, …)
  • Drug administration device (needles, infusion & perfusion, syringes & needles, catheters ,…)
  • Surgical instruments in several healthcare disciplines
  • ….

 

Medium Companies struggling with Headover and / or needing assistance with new projects, regulatory or client requirements have always been served on several domains such as:

  • CaPa handling
  • Needing help with internal audit  (with a fresh new view)
  • Validation of processes
  • Risk management activities
  • Medical writing
  • Design review & planning
  • STED Technical file review
  • Clinical evaluation reports (CER) and PMS review
  • LVL Mediphar can act as interim quality representative, RP for regulatory compliance
  • ...

 

Large corporations needing specific project leaders are always welcome to discuss their needs. LVL Mediphar has experience in both GMP medicinal products and medical devices and has focused on coaching internal or new hired people to accomplish their tasks in several topics i.e.

  • Training needs
  • Product regulatory status compliance
  • Drug – device combinations
  • PMS / PMCF and Vigilance
  • ...