Research & Development (R&D)

Regulatory strategy in Product Development (Design History File, Technical File)

ARQon provides regulatory strategy for Manufacturer on the following as early as concept phase planning to meet the regulatory requirements for medical device:

• Countries to penetrate globally in priority orders based on regulatory approval timeline, efforts on documentation preparation e.g. local trial data, local type testing and other pre-requisite requirements of some countries for benchmarked countries approval
• Testing requirements e.g. Biocompatibility, Electrical safety, Software based on harmonised standards or references which can be different in the targeted countries to meet its Essential Requirements for Medical Device
• Regulatory terms e.g. Classification, Category code, Grouping
• Technical documentation requirements e.g. Design History File, Technical File (STED or CSDT)