TEL.+81-3-5614-2750
OUR BUSINESS
Services offered
Design and Development Outsourcing
We undertake the design and development of medical devices.We customize our services to meet your specific requirements.
- Design and Development plan
- Design and development inputs
- Design and development outputs
- Design and development review
- Design and development verification
- Design and development validation
- Design and development transfer
Design and development support
We provide comprehensive support for the design and development process of medical devices.
- Development process formulation
- QMS Construction
- Investigation of similar products
- Needs Assessment
- Risk management (including safety Information gathering)
- Design specifications, validation
- Preparation of Verification Test Protocol
- Preparation of document for consultations with the PMDA, and conduct of consultations with the PMDA
- Design management (design contractor selection, management outsourcing)
- Prototype Management (Selection of Prototype Manufacturers, Management of Outsourced Production)
- Prototype validation
- Verification Test Management (Coordination with testing organizations, management of outsourced work)
- Validation of Test Results
Regulatory affair of consulting support
We provide comprehensive consultation regarding regulatory applications for the domestic market launch of medical devices. We formulate precise regulatory strategies and provide implementation plans.
- Design and development support
- Formulation of Application Strategy (Evaluation of Application Category)
- Agency services for consultations with local governments and review bodies
- Establishing internal systems (QMS, GVP) in response to revised pharmaceutical regulations.
- Services for advising on required documentation and determining eligibility for use (data review)
- Consulting for ISO 13485 certification
Support for preparing regulatory affair documentation
We provide support for the creation of various documents based on the Pharmaceutical Affairs Law.
- Tasks related to applications for medical device manufacturing and marketing approval (supporting documentation)
- Tasks related to applications for certification of medical device manufacturing and marketing
- Application for Marketing Authorization and Manufacturing Registration
- QMS and GVP Documents (Subsystems)
Support for creating clinical trial-related documents
We prepare various documents related to clinical trials in accordance with Medical Device GCP.
- Clinical trial design
- Clinical trial protocol
- Clinical trial device
Business Track Record
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| 2025年 | 2024年 | 2023年 | 2022年 | 2021年 | 2020年 | 2019年 | 2018年 | 2017年 | 2016年 | 2015年 | 2014年 | 2013年 | 2011年 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Consulting regarding Regulatory Affairs |
27 | 18 | 25 | 43 | 57 | 32 | 26 | 21 | 28 | 18 | 41 | 28 | 51 | 32 |
| Applications for Approval | 11(11) | 16(15) | 25(23) | 28(22) | 23(18) | 21(15) | 25(20) | 28(19) | 25(20) | 18(11) | 13(9) | 15(13) | 17(11) | 15(12) |
| Applications for Certification | 15(15) | 38(28) | 40(38) | 36(24) | 17(14) | 33(26) | 40(29) | 32(24) | 37(29) | 32(20) | 36(28) | 45(29) | 31(18) | 42(15) |
| Notification of Medical Device Manufacturing and Marketing |
21(21) | 10(10) | 8(8) | 20(20) | 54(50) | 28(14) | 18(10) | 25(18) | 10(8) | 11(4) | 28(20) | 25(21) | 15(5) | 11(3) |
| Support for QMS/ISO13485 Implementation |
8 | 8 | 19 | 18 | 17 | 20 | 16 | 21 | 10 | 16 | 22 | 16 | 12 | 14 |
| Support for Clinical Trials | 0 | 0 | 0 | 4 | 0 | 3 | 1 | 1 | 2 | 1 | 2 | 1 | 1 | 2 |
| Veterinary medical devices | 1 | 1 | 3 | 2 | 1 | 2 | 2 | 3 | 5 | 2 | 4 | 2 | 1 | 3 |
| Seminar on Regulatory Affairs for Medical Devices (Total Number of Participants) *2 |
- | - | 132 | 165 | 96*1 | 138*1 | 195 | 180 | 205 | 246 | 220 | 177 | 211 | 115 |
| Support for new market entrants *3 |
- | - | 5 | 12 | 4 | 11 | 16 | 20 | 18 | 10 | 13 | 8 | 6 | 4 |
* Results from January to December of each year.
* Figures in parentheses ( ) indicate the number of imported products.
*1 Partially suspended due to prevention of spread of new coronavirus infection.
*2 “Support for new market entrants” were transferred to "Health Tech Co-Creation Foundation" effective July
2024.
*3 “Support for new market entrants” were transferred to "Health Tech Co-Creation Foundation" effective
2025.
Devices (Key Track Record)
- Stent（Coronary artery, gastric and duodenal, colon, ureter, urethra）
- Catheter（PTCA、intracranial、tracheal）
- Central circulatory embolization coil
- Hemostatic clip
- Hemostatic agent
- Analyzing software for hemodynamics or cardiac function
- Supporting software for dental orthodontics treatment
- Workstation Software
- Artificial dura mater
- Artificial hip joint
- Implantable fixation plate/Screw
- Dental bleaching agent
- Dental implant
- Infusion device
- Multiparameter monitor with critical parameters
- Radioisotope Synthesis System
- Laser device (CO2, YAG, Diode)
- PRP kit
- PET-CT
- MRI
- Ultrasound imaging system
- Bronchoscope
- Infusion/drainage needles(blunt needles、standard needles)
- Suture
- Dental X-ray system
- Dental handpiece
- Endodontic apex locator
- Dental material
- Low frequency therapy equipment
- Massager