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