You've made it to the marketplace, but your ability to maintain product viability is constantly challenged. Whether introducing changes to the device, monitoring actual use success rates, or dealing with occasional inspections, MDCI can help you stay in business.

We provide consulting on regulatory compliance issues:

Preparation for FDA inspections and registrar or Notified Body assessments

Enforcement action responses and/or corrective action plans

FDA-mandated Annual Certification Audits

Recall strategies

Due diligence audits

Facility registration and device listing

U. S. Agent Service

European Authorized Representative

And we can handle post-market surveillance:

Complaint handling, MDR and Vigilance reporting, failure investigation, and problem reporting

Device tracking

We also design and manage post-market studies, provide temporary on-site quality/compliance staffing and support, and perform product change assessments for regulatory submission impact:

Premarket approval (PMA) Supplements

Premarket notifications [510(k)s]

Speak with a Consultant

Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or click here and a consultant will contact you directly.