Surgical Medical Devices
Boston Engineering provides product design and engineering consulting from concept development through commercialization. We combine innovative thinking, technical experience, and regulatory insights to develop new capabilities that empower surgeons, physicians, and clinicians to advance patient care.
Certified for ISO 13485:2016 standards, Boston Engineering applies its phase-gate development process to:
• Accelerate New Product Development: Boston Engineering translates groundbreaking ideas into successful products, and has a proven track record helping clients bring FDA and CE cleared products to market.
• Mitigate Risk: Extensive research and feasibility analysis early in the innovation process eliminates problems later in the development cycle. Boston Engineering addresses risk for both the product and the project.
• Cut Costs: We identify opportunities to reduce production costs throughout the product development process. For current products, we address the supply chain and regulatory issues associated with obsolescence to extend the product lifecycle and to trim costs.
• Apply Compliance Expertise: Boston Engineering provides the industry knowledge to minimize the time and expense associated with global regulatory requirements (e.g., US FDA Clearance, EU CE Mark, etc.).
Our quality management system (QMS) ensures compliance throughout each product development phase. Using our certified design control procedures, we collaborate with our customers to create and maintain the design history file (DHF) documentation required for rigorous compliance reviews.
We drive innovation throughout the surgical suite, including:
- Diagnostic radiation (x-rays, MRI, etc.)
- Ear, nose, and throat (ENT)
- General surgical equipment
- General surgical instruments
- Obstetrics & gynecology
- Sports medicine
- Surgical robotics