Using our technologies as the base and drawing on three decades of experience in medical device product and business development, we provide support and consulting services in R&D to customize our best-in-class products to your application and target market.
We assess commercialization potential through detailed economic modeling and analyze the results with you to determine your development and manufacturing strategies.
Efficient process design is critical in medical device development and manufacturing. As part of a product development and manufacturing program focused on application-specific versions of our technologies, we provide fully documented process design services to ensure production that is optimized for cost, reliability and consistency. Our facility includes Containment Level I and II biology labs where we can perform comprehensive cell and tissue evaluations.
Our processes are fully documented according to our Quality System, which has been audited against FDA, Health Canada and CE standards and is certified to ISO 13485 and ISO 9001 requirements. We provide complete audit-ready Design History Files (DHF) and Device Master Records (DMR) for your processes.
Octane provides end-to-end management of product and process validation – from developing Validation Master Plans to delivering validation protocols and reports. We apply our extensive experience in risk management and GMP manufacturing to ensure all products consistently meet documented specifications and regulations.
Our services include validation within our ISO certified manufacturing facility as well as experienced coverage of external processes such as medical device sterilization.
Getting regulatory approval for medical products is often a complicated process, especially if you’re in an unfamiliar market. Octane eases the way by undertaking regulatory approval of the products generated through our collaboration.
We have the systems and expertise in place to take care of medical product registration and approval in your target jurisdiction, so you can bring your customized product to market as quickly as possible.
We’ve got 40,000 square feet of state-of-the-art space for product development and manufacturing. But we offer more than space – we have the experience, capacity, ISO-certified environment, and standards-based systems to meet your production goals.
Focused primarily on medical device production in Class 1,000 to 10,000 controlled environments, our manufacturing services span a broad range of processes, including chemical synthesis, surface treatments, ultrasonic welding, UV bonding, and sterile barrier packaging. Flexible manufacturing workstations supported by the latest in automation allow us to accommodate specialized assembly and inspection activities.