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Supporting in planning and
implementing medical device business strategies and
new business development strategies
Supporting in establishing, maintaining,
and operating a quality management system
Regulatory Development Strategy
Supporting in planning and
implementing regulatory strategies
during new product development
Hands-on Consulting
consulting services provide highly specialized support in resolving challenges related to the development and marketing of medical devices, the establishment of quality management systems, and the planning of strategies for obtaining regulatory approval, based on an understanding of our clients' business challenges.
We work with the client to install systems and processes
and execute with them to maintain sustainability.
We don't just do the work on their behalf.
Example of Hands-on Consulting
Example of consulting for a major Japanese manufacturer in the medical device business
Clarification of challenges
•Hearing
•Gap assessment through on-site analysis
•Confirmation of objectives, goals, scope and deadlines
Improvement Plan
•Proposals for Improvement
•Coverage check
•Confirmation of feasibility
Implementation of remedial measures
•Launch of joint SiM/Client project
•Professional Support
•Progress Check