Modulus' expertise in implantable devices is built on almost four decades of experience in the development and manufacturing of high reliability, ultra low power microelectronic products. We have developed several implantable devices such as a gastric stimulator for the treatment of obesity, a device for congestive heart failure, neuromodulation devices, drug delivery platforms and drug-device combination products.
The robust quality philosophy and quality systems that Modulus has created are well suited for the demanding requirements of implantable devices. Product development begins with a very detailed and thorough Product Specification and Requirements document, which is reviewed and approved by our customers working with our engineers and project managers. We then create a detailed Project Plan with milestones and Design Reviews at appropriate points in the development.
During the product development phase, we develop qualification protocols for each of the sub-systems of the implantable device. We can also provide complete testing and report generation. In addition, we provide support with EMI, shock & vibration, and drop testing for IDE and CE mark applications. Our QA engineers supervise any product returns and perform failure analysis. Failure analysis reports on all product returns are provided to our customers.
Modulus Quality Assurance, working with customer's requirements, drives the internal manufacturing process validation and test systems qualification. Complete product qualification includes EMI testing, shock & vibration testing, temperature cycling and sterilization validation.