Medical Device Development Support Service
Extensive PMDA Experience Is Our Greatest Strength
Consulting Service
Offering the best solutions envisioning the goal from the view points of regulatory body
Each medical device requires different data to ensure efficacy and safety depending on its clinical roles. In other words, how you define a medical device’s clinical implications can lead to a variety of development strategies to choose from, and the path to achieving the goal will be very different depending on the choice you make.
At TUKC, we support customers to efficiently develop medical devices based on our extensive knowledge and experience in medical device development, including development support and regulatory reviews. We achieve this by conducting a comprehensive assessment, including what strategies are available and what challenges each choice will pose, and offering the best solution that envisions the goal.
Medical Writing Support Service
Helping to prepare credible and convincing documents based on our extensive experience in the field
Medical device development requires preparation of different documents in different phases, including PMDA consultations, non-clinical tests, clinical trials (clinical tests), and applications for approval. The ability to prepare convincing documents for the PMDA and reader-friendly documents for stakeholders in non-clinical and clinical tests can make a significant difference in the speed of medical device development.
TUKC is staffed with members who deeply understand the viewpoints of the regulatory body through their review experience at the PMDA, as well as members with experience in preparing documents for PMDA consultations, non-clinical tests, clinical trial management, and applications for approval. Leveraging their extensive knowledge and experience, we will support the preparation of effective documents in each phase.
Areas of Support
- Robotics
- AI・ICT
- Orthopedic and plastic surgery
- Psychiatry and neurology
- Respiratory
- Neurology
- Vascular
- Gastroenterology and Urology
- Dental and oral
- Ophthalmological and ENT
- Cardiovascular
- In vitro diagnostics
We cover all these areas
Do these problems look familiar to you?
Without enough support, some development projects fall through and never resume...
With the timely support of TUKC,
you can take the shortest path to development in line with the PMDA’s viewpoint!
Problem solving and commercialization through consistent support
by TUKC and CRIETO
The success of medical device development strongly depends on the quality of the development strategy. Clinical Research Innovation and Education Center, Tohoku University Hospital (CRIETO) is staffed with members who have worked for the Pharmaceuticals and Medical Devices Agency (PMDA), the Ministry of Health, Labour and Welfare, and the Japan Agency for Medical Research and Development (AMED). The Center has a solid track record of providing support, such as preparing development strategies based on scientific evidence while leveraging its staff’s experience.
Through collaboration and cooperation with CRIETO, Tohoku University Knowledge Cast will further improve its services tailored to customer needs. We also strive to enhance and expand our high-quality consulting service by building more flexible systems, including the co-creative development consulting service that offers consistent and detailed support throughout the process, as well as guidance and support in preparing documents to be submitted to the PMDA.
- Consultation
- Medical writing support
- Clinical studies
- Development seminars
- In-house training
Workshop service
We offer a variety of training programs, lectures, and seminar instructors tailored to each customer’s needs related to medical device development.
- Do you have questions about our services or TUKC?
Please feel free to contact us anytime. - Contact Us
