Expertise
From product transfers to next generation designs to new product development – our devices are all tailored to align with the crucial stage gates of our customers. Our process begins with meticulous project planning, emphasizing design confirmation, prototyping, and master validation planning. From there, we transition into the verification and validation phase, and the implementation of lean manufacturing for ongoing production.
Project Planning
Project Planning
Our engineers collaborate with customers to evaluate designs and ensure the expected outcomes. To mitigate the intrinsic risk of new designs, we produce prototypes.
Verification
Verification
To ensure prompt delivery of parts and boost confidence in your device performance, GII creates verification samples. These samples, used for early product testing to verify performance, are made in a sample room using production tooling but without formal production documentation.
Validation
Validation
After approval of verification parts, we proceed with validation activities. This involves creating process documentation, executing validations (IQ, OQ), building initial production lots (PQ), and collecting data.
Production
Production
The goal of production goes far beyond providing quality product on time. We provide a personalized approach where every customer has a dedicated team to support all aspects of on-going production.
Quality-Driven, Process-Focused
A product is only as good as its process. And at Global Interconnect, we’ve worked tirelessly to develop a streamlined yet comprehensive medical device design and manufacturing process that maximizes cost savings, upholds the highest quality standards, and ensures successful project execution.
Blank First
Pre-Project
Defining Business Goals: We collaborate closely with our clients to understand their specific business goals and objectives for the project.
Solution Discussion: Through intensive consultations, we engage in detailed discussions with our clients to explore various design and manufacturing solutions that align with their goals and regulatory requirements.
Quote Review: Our experienced team reviews and analyzes project requirements to provide accurate and competitive quotes that meet the client’s budgetary constraints while ensuring compliance with industry standards.
Product Development: Based on the agreed-upon solution, we initiate the product development phase, employing our expertise to ensure a solid foundation for achieving exceptional outcomes.
Project Execution
Part 1: Drawing/Modeling, Prototype, and Project Planning: Leveraging advanced technologies and industry best practices, we develop detailed drawings/models and prototypes that enable effective project planning and facilitate client feedback.
Part 2: Verification and Validation: Rigorous verification and validation processes are implemented to ensure the developed medical device or sub-assembly meets the defined specifications, regulatory requirements, and quality standards.
Production
Production: With our state-of-the-art manufacturing facilities and a dedicated team of skilled professionals, we execute the production phase with a focus on precision, quality, and adherence to strict regulatory standards. Our robust quality processes guarantee the production of safe and reliable medical devices.
Delivering Quality Products on Time: Throughout the entire process, we place paramount importance on delivering high-quality medical devices within the agreed-upon timelines. Our commitment to on-time delivery ensures that our clients can meet critical healthcare needs promptly.
Continual Improvement & Optimization
Design and Process Optimization: At Global Interconnect, we prioritize continuous improvement and optimization of our designs and manufacturing processes. Through advanced engineering techniques and feedback loops, we enhance efficiency, reduce costs, and accelerate time-to-market while ensuring compliance with applicable regulations.