Our Approach to Medical Devices
We understand that the medical devices we make have the potential to change lives. That’s why we take our responsibility seriously. Learn about our focus on quality, our supportive services, and more by clicking the links below.
Our medical device manufacturing team focuses on quality above all else. We utilize an ISO Class 7 Cleanroom to create high-quality medical devices.
Our lean production process and connection with medical device industry assets aid your manufacturing process and help you succeed.
WE FOCUS ON QUALITY
The medical devices we make have the potential to change patients’ lives. We take that responsibility very seriously. That’s why we’re ISO 13485:2016 certified and FDA Registered. We also hold a Japan Foreign Medical Device Manufacturing certificate. With MediSurge, you know your medical devices are in good hands.
PROACTIVE AND REACTIVE MEASURES
When we create a medical device, we focus on quality in all aspects of the process. Some of our unique quality measures include:
Trending metrics. We monitor trending metrics for even the slightest variations so we can react quickly.
Customer complaint rates. We look closely at all customer concerns. The industry standard rate is between 3-5%. In 2019, ours was at 0.014%.
Quality watch. Our production manager spends their entire shift inside of our Class 7 Cleanroom to actively monitor production.
Quality heroes. We reward our staff for noticing areas for improvement. We also empower any member of our staff to halt production at any time for immediate inspections.
These methods, among others, are how we can keep scrap low, produce high-quality medical devices, and operate at a cost that makes sense.
EVERY STEP OF THE WAY
When we say that we want to be your partner, we really mean it. That’s why we’re proud to offer a variety of different supportive services, no matter where you are in your medical device journey.
OUR SUPPORTIVE PROCESSES
We stand with you throughout every step of the process. From the moment you contact us onwards, you can expect:
- A thoroughly vetted medical supply chain
- Quality device assembly in our Class 7 Cleanroom
- Efficient device packaging
- Ongoing inventory management
- Reliable transfer programs
- Significant discounts for large volumes or combined orders
- And more
We work with certified and trusted supply chain partners and vendors to help your medical device journey go smoothly.