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Medical Device Development Company

We specialize in minimally invasive, complex medical device development and manufacturing.
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Rev.1 Engineering is a medical device development company that specializes in end-to-end medical device development, offering a blend of advanced engineering and design. 

Our expertise lies in device design and innovation with our team members averaging 20 years of medical device engineering experience. Whether you’re developing a first-of-kind device or improving on an existing concept, we are prepared to assist you through the entire lifecycle of your device. Our track record includes obtaining regulatory approvals, ensuring your product meets the necessary regulatory requirements.

Our team of skilled medical device engineers is available to assist you at any stage of the development process. We pay close attention to clinical, regulatory, and engineering constraints to meet the requirements for approvals.

Our medical device development process includes:

  1. Program planning and budgeting
  2. Early stage discovery
  3. Design for manufacturing
  4. Verification and Validation
  5. Manufacturing transfer
  6. Regulatory alignment and support
  7. Lifecycle management

Rev.1 Engineering is ISO 13485:2016 certified, reflecting our dedication to quality and industry standards. Throughout the device development lifecycle, we work closely with medical device companies like yours to align their efforts with regulatory expectations, leading to faster approvals. Our strategic manufacturing approach helps bring your medical device to market efficiently.

Contact Rev.1 Engineering for Medical Device Development Company

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Early-Stage Manufacturing

Manufacture your device for verification and validation with Rev.1 Engineering.

Design Transfer

We will help facilitate a seamless transfer to the manufacturer of your choice when the time comes.

Certifications and Quality

We hold an ISO 13485:2016 certification and operate an adaptable Class 7 and Class 8 Cleanroom.