Acceptance is not the end of your success, the next step is to maintain compliance with ISO 13485 and 21 CFR Part 820. You will need to participate in after-sales monitoring activities to further monitor the safety and effectiveness of the medical devices you sell.
HMC will help you:
● Medical device risk management
● System tuning and optimization
● Develop a PMS plan
We will rely on your market to offer the most suitable solution.