MedTech industries encompass a wide range of technologies going from conventional mechanics and electronics engineering to the most advanced solutions including:

  • Software, either embedded, or based on cloud computing, or even machine learning
  • Bio technologies, for example for resorbable implants and wound dressing
  • Combination with medicinal products with an ancillary purpose
  • Use of molecules that have historically been considered as medicinal for a non-medicinal purpose
  • Nano engineering for specific surface or structural behaviors
  • 3D printed structures for implants or other structural devices
  • Microfluidics for the purpose of diagnosis, such as lab-on-chip, or body fluid management
  • Integrated hybrids for active implants

The deployment of manufacturing processes, especially if they are subcontracted, requires extensive care.

Medidee is there to help you identifying a path forward, finding solutions for compliance and implementing these with your team and suppliers.

The typical deliverables include:

  • Technology assessments to identify regulatory, quality and clinical impacts
  • Setup of pre-clinical testing, if required with the use of reference laboratories
  • Build-up of Master Validation Plans (MVP) for controlling process validation