Natasha Bond 0:03
I should tell you a little bit about ERI Group. We are a service provider to the medical device industry. We have been around for about 35 years. We're about 100 people we focus not exclusively, but with a lot of passion and dedication to the most complex multifunctional devices. The more difficult and more disciplines of engineering required to make them work the happier we are. I have been quoted as as explaining that med devices basically fit into a couple of different categories, you can be software, you can be an implant, you can be a tube, you can be a box, we do boxes.
We are very happy and excited to start very early in the product development stage with our team of very capable industrial designers. We then hand it over to our teams of engineers mechanical electrical software systems before bringing in the quality and regulatory folk, and then moving into domestic fully managed low to moderate volume manufacturing, which we can offer from a zero volume with fully managed design for manufacturing, engineering services and supply chain management, and I am very excited to say that we have opened our new domestic manufacturing site this week. So we have 34,000 square feet. The team has just messaged me to say that the last truck is unloaded. The first line is revalidated and up and running. And yeah, rockin and rollin.
A proven leader in medical device program delivery, with 20+ years experience integrating technical and commercial teams for success. Specific focus on enabling small, often venture funded medical device companies to commercialization efficiently and effectively. Skills include:
• New Product Development and Commercialization – business case and user needs identification and translation to product realization. Risk-Based development strategy and implementation of least-burdensome approached to accelerate development lifecycles
• Medical device development from concept to launch – Vascular, Venous, Respiratory, Gynecological, Analytical testing and diagnosis, Drug Delivery, Wearables.
• Project and Program Management, PMO
• Regulatory Strategy & submissions, including PMA, 510(k), EC Tech File, Canada, Japan, FDA pre-submission and communication management.
• Regulatory compliance and quality system implementation, ISO13485 / ISO-14971/21-CFR-820 compliance
• Change management, communication, facilitation, cross-functional coordination
• Due diligence and post-acquisition integration
Chartered Mechanical Engineer and PMP
Advisor, Educator and Mentor through 8 accelerator / incubator organizations to dozens of medical device start-ups.
A proven leader in medical device program delivery, with 20+ years experience integrating technical and commercial teams for success. Specific focus on enabling small, often venture funded medical device companies to commercialization efficiently and effectively. Skills include:
• New Product Development and Commercialization – business case and user needs identification and translation to product realization. Risk-Based development strategy and implementation of least-burdensome approached to accelerate development lifecycles
• Medical device development from concept to launch – Vascular, Venous, Respiratory, Gynecological, Analytical testing and diagnosis, Drug Delivery, Wearables.
• Project and Program Management, PMO
• Regulatory Strategy & submissions, including PMA, 510(k), EC Tech File, Canada, Japan, FDA pre-submission and communication management.
• Regulatory compliance and quality system implementation, ISO13485 / ISO-14971/21-CFR-820 compliance
• Change management, communication, facilitation, cross-functional coordination
• Due diligence and post-acquisition integration
Chartered Mechanical Engineer and PMP
Advisor, Educator and Mentor through 8 accelerator / incubator organizations to dozens of medical device start-ups.
Natasha Bond 0:03
I should tell you a little bit about ERI Group. We are a service provider to the medical device industry. We have been around for about 35 years. We're about 100 people we focus not exclusively, but with a lot of passion and dedication to the most complex multifunctional devices. The more difficult and more disciplines of engineering required to make them work the happier we are. I have been quoted as as explaining that med devices basically fit into a couple of different categories, you can be software, you can be an implant, you can be a tube, you can be a box, we do boxes.
We are very happy and excited to start very early in the product development stage with our team of very capable industrial designers. We then hand it over to our teams of engineers mechanical electrical software systems before bringing in the quality and regulatory folk, and then moving into domestic fully managed low to moderate volume manufacturing, which we can offer from a zero volume with fully managed design for manufacturing, engineering services and supply chain management, and I am very excited to say that we have opened our new domestic manufacturing site this week. So we have 34,000 square feet. The team has just messaged me to say that the last truck is unloaded. The first line is revalidated and up and running. And yeah, rockin and rollin.
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