Complying with standards during design development for medical devices

Various standards must be met during the design development process for medical devices, and the wide variety of these standards and other requirements present a significant obstacle to the development of medical devices.

SunFlare can assist you in complying with the various standards for medical devices (including ISO 14971 and IEC 62366) to complete the procedures required under Japan’s Pharmaceuticals and Medical Devices (PMD) Act and other international regulatory affairs.

Marketing process for medical devices

Marketing process for medical devices

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*Compliance with various standards is mandatory in the marketing process up to design and development and various tests and evaluations (steps outlined in red).

Consulting services provided by SunFlare

Design development and technical documents

We assist in organizing design inputs and drafting various technical documents in preparation for marketing a device in Japan and overseas. As part of this assistance, we:

  • Identify the requirements and standards that apply to the product (including those that apply in Japan, the US, the EU, and other parts of the world)
  • Analyze the client’s current compliance with the above-mentioned requirements or other applicable standards and assist in resolving any nonconformities
  • Work with the client to establish performance and safety standards and examine the verification method
  • Examine the endpoints of the pre-clinical and clinical studies for the product
  • Provide advice on conducting design verification and validation

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Key medical device standards

We assist in ensuring compliance with standards for medical electrical equipment (JIS T 0601-1 [IEC 60601-1, Edition 3.1]).As part of this assistance, we:

  • Hold detailed lectures on JIS T 0601-1 (IEC 60601-1, Edition 3.1) (as well as issue training completion certificates)
  • Analyze the client’s current compliance and assist in resolving any nonconformities
  • Address issues related to compliance with usability engineering requirements (IEC 60601-1-6)
  • Provide procedure manuals and sample documents
  • Draft study protocols

We assist in ensuring compliance with risk management standards (JIS T 14971/ISO 14971). As part of this assistance, we:

  • Hold detailed lectures on ISO 14971 (as well as issue training completion certificates)
  • Work with the client to examine the characteristics of the medical device in relation to its intended use and safety
  • Work with the client to identify hazards, hazardous situations, and potentially harmful incidents from a risk management perspective
  • Provide samples of risk management files, including a Risk Management Plan

We assist in ensuring compliance with standards for usability engineering (IEC 62366). As part of this assistance, we:

  • Hold detailed lectures on IEC 62366 (as well as issue training completion certificates)
  • Provide samples of usability engineering files
  • Review and provide feedback on usability engineering files prepared by the client
  • Draft usability engineering files

We assist in ensuring compliance with standards for software medical devices (JIS T 2304/IEC 62304). As part of this assistance, we:

  • Hold detailed lectures on JIS T 2304 (IEC 62304) (as well as issue training completion certificates)
  • Analyze the client’s current compliance and assist in resolving any nonconformities
  • Provide procedure manuals and template documents
  • Review and provide feedback on documents related to the software lifecycle process prepared by the client
  • Draft documents related to the software lifecycle process

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