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
Company Details
- Employees
- 6
- Founded
- -
- Address
- Redmond, Oregon 97756, Us
- Industry
- Medical Device
- Website
- vision28.com
- Keywords
- FDA Consultants Medical Devices, 510(k) Clearance, Simplify Quality Systems, Virtual Quality Department, FDA-483 Remediation, CFR 820 & ISO13485:2016.
- HQ
- Redmond, Oregon
Vision28 Questions
Vision28's website is vision28.com
Vision28's LinkedIn profile is https://www.linkedin.com/company/vision28
Vision28 has
6 employees.
View email and phone details for 6
employees at Vision28.
Vision28's industry is
Medical Device
Vision28's categories are Medical Device
Vision28's founding year is 2014
