Planning seminars and other events

With the medical device market expected to continue growing, increased efforts are being made in Japan to raise the industry's competitiveness and stimulate innovation. Compliance with the complex regulations and various types of standards that apply in this industry is essential in the marketing of medical devices.

In light of this, SunFlare shares the expertise and practical regulatory knowledge that it has gained through the provision of medical device consulting services by conducting a variety of seminars, human resource development programs and other events for stakeholders in the medical device market.
Upon request, we conduct seminars developed in-house as well as lectures tailored to various courses and seminars organized by local governments and industrial promotion groups.

Examples of events offered

On-site seminars (for corporations)

We offer on-site seminars tailored to specific purposes on a range of topics, from compliance with new laws and regulations to education and training. The following are a few examples of topics covered in past seminars.

  • Basic introduction to the laws and regulations of Japan, the US and the EU (for in-house education and training programs)
  • Transitioning to the EU's Medical Device Regulation (MDR) (compliance with new regulations)
  • ISO 13485:2016 (preparation for entry into the medical device market)

Courses and workshops (for local government organizations, chambers of commerce and industry, and supporting organizations)

We offer courses and seminars for local governments, chambers of commerce and industry, and supporting organizations. The following are a few examples of topics covered in past courses and workshops.

  • ISO 13485 (for suppliers)
  • Pharmaceuticals and Medical Devices Act (for companies that are entering the medical device market)
  • Overview of regulations in the EU, the US, and Southeast Asia

Human resource development programs

We offer training programs for human resources in the medical device industry. The following are a few examples of topics covered in past programs

  • Regulations for medical device software (IEC 62304)
  • Risk management standards (ISO 14971)
  • Overview of the Pharmaceuticals and Medical Devices Act and basic requirement standards for medical devices

Contact

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