Vision28

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 ISO 13485: 2016 A need for a LEAN, Audit Tested Quality Management System for your small to mid-size company Become aware of the need to conduct or close out a Medical Device Recall We can help! With over 20 years of experience in the medical device quality assurance and regulation industry, as FDA Consultants Medical Devices we can assist you with… Writing 510(k)s for complex electro-mechanical devices and Software as a Medical Device Preparing facilities and training employees to optimize FDA and ISO inspection and Quality 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

• Employees 6
• Founded 2014