SiM Value

We work alongside and install systems and processes
that can be continuously operated and maintained

in the constantly changing medical device industry.

Service Flow

step 1

Assess Current Status and Gaps

step 2

Set Milestones, Actions & Tasks Plan

step 3

Develop Peoples and Processes based on plans

step 4

Confirm Effectiveness

Introduction of Service Flow and Example of Hands-on Consulting

Introducing the process for providing SiM consultant services and examples of consultant support.

Example of Hands-on Consulting : Client's Goal

We would like to resolve operational issues on the quality management system in order to manufacture and sell medical devices sustainably.

STEP

Assess Current Status and Gaps

Align client’s goal and assess gaps to clarify strengths and weaknesses.

Example of Hands-on Consulting

  • Assessment of current status and gaps

Assess goals and objectives, scope of application and operations

Assess competitiveness and business environment

Create gap assessment report for QMS requirements

STEP

Set Milestones, Actions & Tasks Plan

Work together with client to set appropriate milestones and develop actions & task plans that leverage client’s competitiveness

Example of Hands-on Consulting

  • Project establishment

Control project progress as a project management office (PMO)

  • Facilitating training and study sessions

Provide project management training

Facilitate study sessions on standards and regulations required by client

  • Finding the root causes of issues and gaps and creating a freamwork to resolve them

Support for identifying root causes of issues by utilizing the effective tool such as Fishbone and 4Ms (Man, Machine, Material and Method)

Support for prioritizing solutions, setting milestones and creating Gantt charts to show the paths to achieve the goals

STEP

Develop Peoples and Processes based on plans

In the process to solve client’s issue, we will link our many years of practical experiences in the medical device industry and work together to deliver the outputs that is easy to understand.

Example of Hands-on Consulting

  • Execution of the plan

As a Project Management Office (PMO), we manage and support project progress and project sponsor reports.

Managing issues and risks that arise during execution

Providing expert and specific advice based on SiM's experience to ensure the right deliverables

STEP

Confirm Effectiveness

By providing through hands-on consulting support through total project management and working together to achieve goals, we contribute to strengthening organizational capabilities and processes.

Example of Hands-on Consulting

  • Check the effectiveness of the action

Confirm the effectiveness of the revised process, manual implementation, and problem resolution

Evaluation of ongoing efforts to resolve issues and problems

Building an organization and process that can operate and maintain continuously

in constantly changing medical device industry