Technical / Clinical / Quality Documents

Quality and Tech Advisory

MedtechBOSS provides advisory, set-up and maintenance for

 

Manufacturer:

Technical Documentation (Technical File, Medical Device File, Design History File, Clinical Evaluation, PSUR)

Quality Management System (ISO 13485, US QSR, GMP, MDSAP, CE MDR, CE IVDR)

Distributor:

 

Quality Management System (GDPMD, GDP)