Easy-Regulatory
FDA, EU MDR/MDD, Regulatory Affairs specialists. We can develop Software as well as SaMD as per ISO 62304 standard.
Overview
We are a team of Regulatory experts who are working on Medical devices for more than 15 years. One team members have been working with some multinational companies as well as authorities based in the US and EU. We are very much familiar with the regulations and the style of working. Areas of expertise: USA: FDA-510k submission Small business certificate EUA Establishment registration Product Labeling QSubmission EU: MDD/MDR Health Canada Risk Management-ISO 14971 Usability Engineering QMS-ISO 13485 We can also perform internal Audit for companies who want to ensure that the have fully complied QMS ISO 13485 in place Feel free to contact us
Upwork activity
Hourly rate
$90.00
Total jobs
0
Member since