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Reporting

Since December 13, 1984, the FDA Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. The Safe Medical Devices Act (SMDA) of 1990 provided FDA with two additional postmarketing activities, Postmarket Surveillance for the monitoring of products after their clearance to market and Device Tracking for maintaining traceability of certain devices to the user level.

  • different time frames for reporting
  • use of standardized reporting forms
  • removal of unanticipated temporary impairments
  • new definitions
  • addition of an FDA disclaimer
  • removal of the "per se" rule

For more information, please call us at (855) 541-2862 or send an email to info@medsol.com.

What Makes Us So Special

  • Our price structure is highly competitive
  • Our clients love us. We have superb references!
  • We are accurate and provide a great turnaround time.
  • Large or small volumes of work.

What Clients Say About Us

avator
We enjoy a very valuable relationship with Medsoltech and look forward to many more years of mutual success.
Dr. Hamid Mahmood (Internal Medicine)
avator
From something bad, we found something good. Thank you, Waqas and your team, for years of wonderful and dedicated service.
Dr. Farhan Qureshi, Internal Medicine
avator
I have found that the staff at Medosltech is very efficient, professional and thorough. They are by far the best billing service.
Dr. Saud Ahemd Infectious Diseases
avator
Without doubt, you have brought a great deal of comfort to my clients, and I would strongly recommend your services.
Dr. Zahid Infectious Diseases