Post-market services

Post Market Compliance

From assisting with product development and initial submission preparation, HMC creates a corresponding support program to help you bypass warning letters and take corrective actions. You can use the service alone, or with our extensive experience, we always handle every case. Timely, sustainable and economical are our operating principles.

We support projects of all sizes in the life sciences. Our compliance consulting services include:

● 483 comments

● Feedback warning letter

● Remedial strategy

● Labeling and rating the site

● Test analysis and distance

● Fake FDA inspection

● Remedial measures

If you need to support proactive after-market activities, HMC also has a support team available. Services include:

● Pharmacovigilance

● Test Ready Training

● Expert theme support

● Post-market clinical follow-up (PMCF)

● Global vigilance support  

Post Market Surveillance

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.