Whether your product is entirely novel or derivative of existing technology, the long journey to bring a product to market always involves enormous challenges.
Perhaps you represent a start-up that needs to prove feasibility to receive additional rounds of financing. Or a large company that needs to fulfill stage/gate requirements before management will give full approval to a product development project.
Perhaps you face an especially tough technical challenge that requires inventing completely new technology. Or you are looking to develop additional IP. Or you need resources to explore various technology “what ifs” that could lead to new opportunities.
Our technology development engagements often result in delivery of a feasibility or proof-of-concept prototype or breadboard prototype.
As senior professionals who are extremely comfortable operating on technology frontiers where little is known and much is to be discovered, we can help you develop creative solutions to the toughest early-stage mechanical and electrical engineering challenges to be faced on the cusp of medical product invention. Our long-time focus on the healthcare industry and our disciplined processes will put you at ease as we work together toward developing new and exciting medical devices.
We’d be excited to partner with you on a mission to discover the recipe for the “secret sauce” that will differentiate your product from others.
The FDA has high expectations for the effectiveness, safety, reliability of your product, as well as for the documentation that supports product claims. Being specialists in developing medical products, we have the skills, experience and strategies in place to make the FDA submission process go smoothly for you.
We hold the latest ISO 13485 certification, the global standard relating to medical device development. Having met specific requirements for its quality management system as determined by a third-party auditor, we have been found to provide product development services that consistently meet customer and applicable regulatory requirements. Aligning our processes with best practices and regulatory needs provides added assurance that product development will proceed smoothly, with minimal risk.
Beyond that, we have great experience and familiarity with IEC 60601 electrical standards relating to medical equipment.
Our approach also places great emphasis on the use of design controls to demonstrate that your medical device will be safe, effective and able to meet its intended use. Another tool in our tool-box is verification testing, which assures that the product is built according to the requirements and the design specifications
All of the above strategies and activities play a role in providing essential FDA documentation, a key to avoiding regulatory delays that can break budgets and adversely affect time to market.