IVD & DEVICE COMPLIANCE

Post Market Surveillance

HMC supports medical device companies with post-market surveillance plans and risk-management work under applicable US and European requirements. Activities are scoped to the product, market and existing quality management system.

Service at a glance

Service at a glance
ItemDetails
ProviderHopkins MedTech Compliance
ForMedical device companies
WorkPost-market surveillance planning and risk-management review
Rules and standardsApplicable US and European post-market requirements
White coat and stethoscope with digital medical icons, from the original HMC website

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.

Read the original website record
CONTACT HMC

Discuss your study
or regulatory submission.

Tell us your product type, target market,
and the support you need.

Contact HMC
Hands using an office telephone, from the original HMC website

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