Medical Device Registration

Devices that do not require 510(k), PMA or IDE applications must still be registered with the FDA. These devices are class I and II exempt devices. Class I and II exempt device must be registered in order to import into the United States. Companies are required to annually register their establishment in order to keep their device registration current.

Additional Regulatory Consulting Services

• Device Classifications
• 510(k) revisions
• Labeling Compliance
• Quality Systems
• Inspection Readiness Preparedness and Training
  • Pre-Auditing Services
    • Upon receiving the FDA inspections letter, Techlink can come in and pre-audit your facility to ensure that your facility is 21CFR 820 compliant prior to the inspectors arrival.
  • Post Auditing Services
    • After the FDA preforms the cGMP inspection per 21 CFR 820, Techlink can come in to assist with and FDA recommendations listed on the auditing form.
• Medical device translations
• Assist with FDA questions