Capabilities

Broadest range of in-house capabilities for consumable medical devices

Our comprehensive nearshore services for Class I and II consumable medical devices allow you to consolidate sourcing save cost. We develop lasting partnerships with OEMs built on robust, proven capabilities and processes. Our outstanding customer care ensures your products are delivered on time and on budget, with the highest level of quality and precision.

Our scalable services include:

Program management: Organizing & implementing your project

Our project managers in the US and Mexico coordinate cross-functional teams to support you throughout the entire product lifecycle. Our experienced project managers have engineering degrees and are dedicated to your project from proposal to launch.

Whether it’s a product line extension or a manufacturing transfer, we can seamlessly manage anything from low-volume/high-complexity to high-volume/low-complexity programs.

Our project managers leverage:

  • Project management tools to keep milestones visible and identify and mitigate roadblocks before they occur
  • Dedicated and robust phase gate process to move projects from proposal through launch
  • Lean tools such as 3P to focus on mitigating waste through product and process design

Committed to quality

We’ve developed a culture of quality and continuous improvement using the Toyota Production System as the foundation of our operations. Our experienced operations and quality control staff develops a custom quality plan based on each product’s specific requirements.

With active Lean Six Sigma, Kaizen, and 5S programs, our quality system for our manufacturing facility meets or exceeds industry requirements:

  • ISO 13485:2016 certified
  • FDA registered
  • ISO 8 cleanrooms
  • CGMP compliant (US)
  • CE mark compliant (Europe)
  • MHLW compliant (Japan)
  • KGMP compliant (South Korea)

Our robust Corrective Action Preventive Action (CAPA) process is designed to investigate and solve issues and identify and eliminate root causes. We leverage a range of problem-solving tools, including:

  • 5 Why method
  • Fishbone diagrams
  • Design of experiments (DOE)
  • Define, measure, analyze, improve, and control (DMAIC) methodology

iiMED Quality Policy

We are committed to maintaining a Quality Management System that is compliant with all regulatory and customer requirements.

Our focus on quality excellence is critical to providing outstanding customer care.

We work as a team to drive continuous improvement and promote a safe and positive work environment.

Let’s talk about how we can leverage our services to bring logistical advantages, scalability, and cost savings to your Class I or II medical device consumables.