Nectar | ISO 13485 Device Development Information

Nectar has been building complex hardware in regulated environments since 1992. The work sits at the intersection of engineering, quality, and manufacturing. Medical devices, aerospace assemblies, scientific instruments, and high-reliability systems where performance and compliance are not optional. The company is based in Long Beach, California. Engineering and build capability are in-house. Development does not stop at design. Programs move through physical builds, verification, validation, and transfer into production environments. Nectar operates under two independent quality management systems. ISO 13485 covers contract design, engineering, and product development for the medical device industry. AS9100 covers the assembly of electromechanical products for aerospace applications. Each system is scoped to its own regulatory environment. Neither substitutes for the other. Few firms operate under both. This is what allows Nectar to support programs across medical device development and aerospace assembly without crossing systems. Programs are executed at the stages where execution cannot slip. Where design controls need to hold up under audit. Where V&V has to run on a compressed timeline. Where design transfer and manufacturing readiness determine whether a program ships. If your program is approaching design controls, verification and validation, or transfer into manufacturing, tell us what is happening. We will tell you directly whether we can help.