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Our deep bench of consultants in virtually every discipline creates value and mitigates risk by leveraging unparalleled expertise in Japanese laws and regulations.

We provide a reasonable regulatory pathway tailored to your product

In order to sell a medical device, a company must meet the regulatory requirements of each market where that medical device is to be sold.


Our consulting services cover all areas of PMDA / RCB regulation that govern those involved in the production and distribution of medical devices.


BrainCraft evaluates your product to determine compliance with regulations. This will help prepare the filing strategy, claims and intended uses for a complete PMDA / RCB document thus optimizing the review process.


BrainCraft has a high level of expertise in PMDA / RCB regulatory compliance knowledge and implementation. We also have direct experience interacting with PMDA / RCB personnel during inspections, submission reviews, and meetings.

＊ RCB：Registered Certification Bodies


Please contact us directly at info@braincraft.co.jp


or through the form under the CONTACT section of this site.



Achievements

Class ⅣImplantable assistant artificial heart system
Class ⅢImplantable incontinence prosthesis
Class ⅢParticle radiotherapy equipment
Class ⅢRadiation therapy synchronizer
Class ⅢRadioactive compound synthesizing facilities
Class ⅢSoftware for gene variants analysis (for cancer genome profiling)
Class ⅢNeurosurgical navigation unit
Class ⅢOphthalmic laser photocoagulation system
Class ⅢDental implant system
Class ⅢSurgical robot unit
Class ⅡSoftware for general-purpose imaging system workstation
Class ⅡSingle-use ophthalmic knife
Class ⅡX-ray/CT combined positron CT system
Class ⅡSurgical navigation unit
Class ⅡSoftware for ophthalmic camera
Class ⅡSoftware for automatic perimeter/ophthalmic camera
Class ⅡSmall moist heat sterilizer for unwrapped goods
Class ⅡMRI system radio-frequency coil
Class ⅠImplant instrument/material for dental laboratory