This industry-specific guidebook will highlight the strategy and know-how in transforming the manufacturing and distribution operations from opto-mechatronics complied into medical-grade complied requirements. Opto-mechatronics industry can take this guidebook as a self-learning tool to get preparted for migrating into the medical device business.

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In this guidebook, country-specific medical device regulatory requirements for importing and distributing of opto-mechatronics related medical devices will be highlighted. Also, essential technical requirements for business migration to medical device market will be discussed as well in the guidebook. 

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With 3 pilot opto-mechatronics companies participating in the pilot scheme, case studies will be incorporated in the guidebook to illustrate the process and methodology of gap assessment and gap bridging requirement for migration.