Quality
Meeting the Highest Standards
effective
Considerations
We know how important it is to have a competitive and cost-effective device in commercialization. Switchback Medical’s product development team focuses on design, budget, safety, and all other considerations required to bring your finished medical device to market successfully.
Committed to Quality
At Switchback Medical, we are committed to quality. We take great pride in our work and instill trust with our partners by having the following certifications and standards:
- Certified
- ISO 13485 certified
- FDA Registered
- FDA Registered Contract Manufacturer, compliant with the Quality System Regulation
- Risk Management
- ISO 14971:2019 Risk Management
- Controlled Environments
- ISO Class 7 and 8 Certified Controlled Environments
Switchback Medical delivers quality time and time again, let us show you why choosing our team is the right move to get your project to market.