Our ISO 13485 Certified Quality Management System facilitates the regulatory approval process by extensively documenting and tracking risks and design controls throughout the project. Nectar utilizes a phase-gated product development process that takes a new medical device from definition, specification, and design all the way through verification, validation, and transfer to manufacturing.

Medical device software validation is necessary for ensuring the medical device is safe its use. We can assist you in taking medical devices from a concept through market launch, or engage with you at any phase of your process to help accelerate development, minimize risk, and increase profitability.