Bringing medical devices to market more efficiently
There’s no avoiding the risk that the FDA approval process represents for your business. But you can minimize risk in the design and manufacturing phases of your new product by partnering with a firm that has a track record of getting medical device concepts to market—on time and on budget.
Among Gener8’s team of 160 engineers are highly-skilled engineers familiar with medical product design and development. Our team understands the pressures and priorities of companies like yours. To provide the smoothest concept-to-market process, our medical device design and development plan is integrated with our ISO 13485-compliant manufacturing operations. Our combined expertise in both the design and manufacturing of medical devices ensures that your idea becomes a complete product that meets the highest quality standards—and can withstand FDA scrutiny.
Complex products require careful systems planning, as well as rigorous adherence to quality standards. Our quality specialists engage with every project from day one and are integrated into every process. We create the procedures and documentation that ensures standards compliance, durability of components and systems, and a safe and effective operation under a wide range of conditions. Gener8’s flexible, multi-tiered approach balances the quality needs of each project. We are ISO 9001:2015 and ISO 13485:2016 certified by BSI and FDA registered (registration number 3012157621).
