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MEDICAL DEVICE CONSULTING & BUSINESS SUPPORT

Support for Medical Device Development and Manufacturing

Are you facing challenges like these?
We provide the right support for your product's stage and your situation.

Systematize and centralize quality management

QMS SUPPORT ECOSYSTEM

QMS Implementation Areas

QMSRegulatory & standards compliance
Organizational support & specific issues
Audit Support
Improvement
Training
Market Entry
Design & Development
Manufacturing
Post-market
Products
Management & QualityMANAGEMENT & QUALITY
Development & BusinessDEVELOPMENT & BUSINESS
SERVICE COVERAGE

QMS-Based Consultation and Operational Support

7Support Areas

01 / STANDARDS

Standards Compliance

  1. Market Entry
  2. Design & Development
  3. Manufacturing
  4. Post-market
  • QMS (ISO 13485)
  • GVP
  • GLP
  • QSR
  • MDR
  • MDSAP
  • ISO15378
  • We want to obtain ISO 13485 certification.
  • We want to run ISO 9001 and ISO 13485 more efficiently together.
  • We want to comply with the revised QMS Ordinance (MHLW Ministerial Ordinance No. 60 of 2021).
  • We want to comply with post-marketing safety management (GVP).
  • We plan to export medical devices to the US and want to know how to comply with the US QMSR (Quality Management System Regulation).
  • We plan to export medical devices to Europe and want to know how to comply with the EU MDR (Medical Device Regulation).
  • We want to obtain MDSAP (Medical Device Single Audit Program) certification.
  • We want advice on regulatory affairs.
  • We want to learn about the PMD Act.
02 / INDIVIDUAL ISSUES

Specific Issues

  1. Design & Development
  2. Manufacturing
04 / DEVELOPMENT

Development Support

  1. Design & Development
  2. Manufacturing
  • We want to know how to perform design verification and design validation.
  • We want to create a traceability matrix.
  • We want to implement usability engineering in line with IEC 62366-1.
  • We want to establish software life cycle processes in line with IEC 62304.
  • We want to perform sterilization validation (moist heat, EOG, radiation).
  • We want to meet the special requirements for sterile barrier systems.
  • We want to comply with ISO 11607-1 and ISO 11607-2.
05 / SYSTEM

Organizational Setup Support

  1. Training
  2. Improvement
07 / PRODUCTS

Products

  1. Products
  • Implantable Medical Devices
  • Non-active Medical Devices
  • Active Medical Devices
  • Software as a Medical Device
  • We want advice on regulatory compliance for active and non-active medical devices.
  • We want to commercialize software as a medical device (SaMD).
ISSUE

Open the challenge closest to yours to see our support and related projects.

Challenges

We support each area, including standards, specific issues, audits, development and organizational setup, according to your product and your needs.

CONSULTING FLOW

How Our Consultations Work

We assess your current situation, organize the issues, and propose solutions that fit your goals.

  1. STEP 01Identify the issues

    We interview you about your current operations and the goals you are aiming for.

  2. STEP 02Gap analysis

    We analyze the gaps between regulatory and guideline requirements and your current situation.

  3. STEP 03Proposed solutions

    We organize the issues identified and propose priorities and how to implement them.

All Services

SERVICE

For questions or consultations about our services, please call us or use the contact form.

+81-46-204-5377

Hours: weekdays 9:00–18:00 (JST)

Contact Form

Contact

CONTACT

Call usWeekdays 9:00–18:00 JSTContact Us