Business Development Strategy

For companies wish to establish or enter Japanese medical device industry, our professionals with extensive experience in business development in the medical device industry can help you formulate and execute a plan to achieve your business goals.  The areas where our professionals can assist you include formulation and execution of business planning, regulatory and reimbursement strategy as well as KOL management.  Please feel free to contact us if you are also considering expanding your medical device business to Japan.

Quality Assurance Strategy

We are experienced in medical device quality management systems and can help companies that are facing challenges in establishing, operating, and maintaining the quality management systems necessary for the manufacture and sale of medical devices to resolve specific issues.

  • We want to introduce and operate a quality management system based on the "ISO 13485 International Standard for Quality Management Systems for Medical Devices," and we would like to have the consulting support specialized in this area.
  • We want to improve the quality of our medical device products, but would like to know from a third-party perspective what specific improvements we should make.
  • We are preparing for a full QMS inspection, but would like to resolve any issues in advance with a preliminary inspection.
  • We have outstanding needs of incorporating the IEC standards such as Software Lifecycle, Cybersecurity or Useability Engineering etc.. and operating them effectively under our QMS and we would like to resolve them before the product is launched into the market.

Regulatory Development Strategy

We provide consulting support for the development and marketing of medical devices by supporting the process of human resource development, organizational reinforcement, and the creation of new product added value, thereby contributing to the improvement of product competitiveness.

  • There are no personnel in the company who can effectively handle regulatory consultation and preparation of application documents for certification or approval of medical device products, based on the intended use, safety and efficacy of the products.
  • We would like to establish a clinical evaluation of a medical device product and would like some expert advice on how to go about it.
  • We want to accurately respond to customer and regulatory requirements for the design and development of medical device products, but we are not sure what to do and how to do it.