Former FDA Investigator — Medical Devices
Steve Yost
Class III device specialist covering regulatory strategy through pre- and post-market requirements, PMA/510(k) technical writing and ISO 13485.
- Class III Devices
- PMA
- 510(k)
- ISO 13485
- HACCP
Former FDA plus industry experience
Background
Steve Yost is a former FDA Investigator with both Agency and industry experience. His expertise is with Class III medical device products, from regulatory strategy development through pre- and post-market requirements. He performs mock-FDA audits for medical devices, human tissues and complex high-risk (HACCP) foods.
He is experienced writing the technical documents required for US and EU PMA and 510(k) submissions and has particular depth in ISO 13485. Steve has also helped firms build quality systems that went on to pass FDA scrutiny.
What Steve does on an engagement
- Class III device regulatory strategy
- PMA and 510(k) technical documentation
- ISO 13485 quality system build and audit
- Mock-FDA audits for devices, human tissues and HACCP foods
Start a project
Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.