Vision28

510(k) Clearance / Simplify Quality Systems / Virtual Quality Department / FDA- 483 Remediation / ISO 13485:2016 Compliance

If you have…

  • Developed a new medical device, and now you want to get it cleared by FDA
  • Just been called by FDA or your notified body and they will be inspecting or auditing your facility
  • Just received an FDA-483 that you need to respond to in 15 days
  • A quality system that is managing you
  • Compliance with ISO 13485, but you need to upgrade to 13485: 2016
  • A need for a LEAN, Audit Tested Quality Management System for your small to mid-size company

We can help! With over 20 years of experience in the medical device quality assurance and regulation industry, we can assist you with…

  • Writing 510(k)s for complex electro-mechanical and Software as a Medical Device product
  • Preparing facilities and training employees to optimize FDA and ISO inspection and audit outcomes
  • Responding to FDA and ISO inspection observations by creating remedial action plans and preparing responses that anticipate potential objections by the agencies
  • Writing, implementing, managing and defending ISO, FDA, CMDCAS quality systems
  • Implementing fully compliant Quality Management Systems in three weeks or less