ISO 13485

Medical violet  stethoscope lying in white background

(ISO 13485 -2003 Medical Devices )specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

ISO Helpers will get your company compliant to FDA regulations and certified to ISO 13485 in 60-90 days.

A medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent.
Companies that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment.

Eliminate the headache, and trust the our proven process in meeting your timeline and budget for  & ISO 13485 certification FDA Compliance!

SO Helpers have more than 30 years of combined experience, in working with medical devices companies. We understand the challenges with FDA regulations and ISO 13485 compliance.

Webinar or on-site consulting;
ISO 13485 
FDA Compliance
21 cfr part 820 (Medical Devices) Quality System Regulation
510(k) is a premarket submission US
CE Marking Gain market access in Europe

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