business

Medical device development support business

In Medical device development support business, we achieve the high-quality product development corresponding with related laws and regulations with our experience from drugs, medical devices, and regenerative medicine development support.
Our professional teams who have wide experiences and knowledge of electricity, machines, biology, chemistry, and medical, provide you smooth and stable service, and fully support for clinical development, obtaining certification, and preparation for Application for approval.

Medical Device Regulatory Affairs and
Entrusted Business for Clinical Development

Medical Device Development Department

The ministerial ordinance on GCP for Medical Devices requires clinical study for medical devices based on the ethical appropriateness and scientific rationality. Also, under the ministerial ordinance on GPSP, the information of safety and efficacy of medical devices must be collected after the devices goes on the market.
EP Mediate does wide support business including the clinical study for medical devices and post-marketing study based on our wealth of knowledge and experience as a clinical study entrusted CRO(Contract Research Organization).

Clinical Study Service
  • Support of establishment of internal systems and operations for clinical study (support preparing clinical study's SOP documents)
  • Support of selection clinical study site and survey eligibility requirements for principal investigators
  • Support of preparation of Clinical Medical Device Brochure, Protocol, Case Report Form, informed Consent Form Draft
  • Support of preparation of Clinical Trial Plan Notification
  • Support for statistics analysis for Clinical Trial
  • Support of preparation of Documents for IRB Screening the Clinical Trial Site
  • Contract with Clinical Trial Site
  • Monitor in Clinical Trials and Visit Sites Regularly
  • Support for the Case Registration and the Assignment Work
  • Collect Case Report From and Information of Adverse Events
  • Source Data Verification
  • Support for Data Management of Clinical Trial
  • Support of preparation Record Documents
  • Support of preparation of presentation documents and conducting Investigator meetings
  • Support of preparation of summary of Record Documents
  • Support for Clinical Trials Audit
  • Support for meetings with PMDA (Pharmaceuticals and Medical Devices Agency) and compliance reviews
  • Consult on Clinical Trials and Others
Post Marketing Surveillance Service
  • Support of establishment of the system for Post-Marketing Surveillance (SOP preparation support etc.,)
  • Support of preparation of Post-Marketing Surveillance protocol
  • Contract with sites that take the Post-Marketing Surveillance
  • Collect surveys and information of adverse events
  • Support of preparation of Post-marketing Surveillance Reports (Use Surveillance Reports)
  • Consult on Post-Marketing Surveillance and Others

Medical Device Regulatory Affairs Department

In addition to, the legal knowledge, a board range of professional knowledge in various fields is required in Medical Device Regulatory Affairs business.
EP Mediate will continue to adapt rapidly to the changing social needs due to the amendment of pharmaceutical and medical device act (PMD Act) and so on, and we hope that helps you with your shortages of human resources.
We make good use of the knowledge and the expertise of our specialized staff who have wealth of experience to meet satisfaction of our client, and we provide a various services such as wide range of consulting services related to pharmaceutical affairs according to customer requests.

Consulting Service for Regulatory Affairs
  • Investigation of classification in Japan
  • Strategy planning from certification and approval application to approval acquisition
  • Review and consulting on proposal application documents created by clients
  • Support for PMDA interview (PMDA: Pharmaceuticals and Medical Devices Agency, Japanese authority)
  • The others, consultation on the whole of RA, such as Annual Consulting, Spot Consulting, and Support Education and Training( holding on-site seminars).
  • Surveillance for Sites
Service regarding Certification, Application, and Marketing Notification
  • Information on required Documents (Device Overview, Clinical Report, etc., ) for the Certification and the Application
  • Preparation Support of the Certification and/or Application form, and package insert and Summary Technical Documentation (STED)
  • Creation support of various Marketing Notifications
  • Arrangement of chemical, biological, electrical tests to external examination organizations and progress management of the tests
  • Acceptance evaluation of previous Clinical Trials Data conducted overseas
  • Confirmation service regarding GCP compliance for utilizing overseas clinical trials data
  • Support for responding inquiries from PMDA and/or the Third-party Certifying Body
  • Accompanying service of submission of documents to Public Office and/or the Third-party Certifying Body
  • The others, consulting on Application and Marketing Notification.
Support Service regarding License Application
  • Preparing Support New, Transfer, and/or Update Application Form (Marketing Authorization, Manufacture, etc.,)
  • Preparing Support for Product-Quality Standards, and Product Master Formula
  • Preparing Support of Operation Manual Regarding QMS, GQP and GVP, and Clinical Trial Reports
  • Confirmation the Structure and Equipment and Clinical Inspection Equipment before the Site Survey
  • Consultation on Quality Management for the establishment of internal system
  • The Others, Consultation on License Application
Service regarding Safety
  • Support service for GVP(Good Vigilance Practice) after marketing in Japan and/or the other countries
Service regarding Application for reimbursement
  • Preparing Support of application for medical device reimbursement
  • Support for Meeting with Ministry of Health, Labor and Welfare Economic Affairs Division
  • The Others, Consulting on Application for reimbursement

For detailed documents, any inquiries or comments about Medical device development support business, please contact us via the inquiry form below.

Inquiry Form