#Japan #Tokyo #Digital Therapeutics #SaMD QMS Starter Kit #Save Medical

Support for Inexperienced SaMD Development Teams

A new player in the medical technology sector, Save Medical Inc., headquartered in Chuo-ku, Tokyo, is set to launch its innovative support package, the SaMD QMS Starter Kit, designed for teams venturing into the realm of Software as a Medical Device (SaMD). Set to debut on September 1, 2025, this comprehensive kit aims to streamline the development process of quality management systems (QMS) that are essential for market entry in the medical device landscape.

Addressing Developmental Challenges for Startups

In recent years, there has been a marked increase in the demand for SaMD, driven by advancements in digital healthcare technologies. However, the requirement for a robust QMS can pose significant challenges, especially for startups and teams lacking prior experience in medical device development. The SaMD QMS Starter Kit has been developed specifically to tackle the challenges surrounding QMS document preparation and to facilitate smoother operations for teams facing hurdles in the initial stages of development.

Many of these teams often find themselves struggling with uncertainties, such as "where to begin" and "how to balance documentation requirements", compounded by unique regulations that govern software in medical applications. Save Medical brings over seven years of practical experience in assisting with the development of digital therapeutics and SaMD, thereby understanding the "invisible barriers" that hinder progress in this field.

Key Features of the SaMD QMS Starter Kit

1. Comprehensive Template Package: The kit includes a thorough set of templates, featuring quality manuals, procedures, and record formats that address specific requirements for SaMD development. This enables teams to quickly customize the documents according to their needs and regulatory guidelines.

2. Expert Guidance: Created by professionals with hands-on experience in SaMD development, the templates incorporate practical insights to ensure usability even for inexperienced teams. Additionally, Save Medical offers an Implementation Support Plan, where experts can provide online assistance for customized document preparation, regulatory strategy development, and consulting on necessary approvals.

3. Global Compliance: Recognizing the importance of international markets, the SaMD QMS Starter Kit is designed to comply not only with Japanese regulations but also with FDA standards. This forward-thinking approach enables teams to build compliant QMS from the outset, significantly reducing both time and costs when considering global expansion.

Future Direction

Save Medical's primary goal is to make the SaMD QMS Starter Kit accessible to a wide array of development teams. We plan to continuously update and expand the templates based on user feedback and aim to broaden the scope of applicable regulations over time.
Moreover, Save Medical intends to enhance its online support services and to organize seminars to facilitate the sharing of knowledge pertaining to SaMD development. Our mission is to become the most trusted partner for all companies looking to innovate in SaMD development.

Product Overview

• - Product Name: SaMD QMS Starter Kit
• - Launch Date: September 1, 2025
• - Pricing (Excluding Tax):

- Design Development Starter Kit: ¥600,000
- Complete Kit: ¥900,000

• - Contents: A complete set of templates necessary for building a QMS for SaMD products
• - Purchase Method: Available on the official website at SaMD-QMS Website

Company Overview

Company Name: Save Medical Inc.
Location: 3-3-6 Nihonbashi Honcho, Chuo-ku, Tokyo
Presented by: CEO Masataro Asano
Established: May 2018
Business Focus: Support for DTx and SaMD development, and provision of outsourced QMS consulting services.
Website: Save Medical
Certification: ISO/IEC 27001:2022 certification for information security management systems.