— Strengthening support for advanced and global quality and compliance management, in addition to business development consulting for medical device and life sciences companies —
Sanamedi Inc. (Head Office: Chuo-ku, Tokyo; Representative Director: Takehiko Uchida; hereinafter “Sanamedi”) is pleased to announce that it has entered into a service provider agreement for the Japanese market with Dot Compliance (Head Office: Phoenix, Arizona, USA; Founder: Doron Sitbon ), a provider of an AI-powered electronic Quality Management System (eQMS) purpose-built for the life sciences industry.
Under this partnership, Sanamedi will serve as a Dot Compliance service provider in Japan, supporting new customer development, opportunity creation, and sales proposals.
■ Background and Purpose of the Partnership
As medical device and life sciences companies accelerate their global expansion, the burden of complying with stringent regulations and standards in different countries and regions, including FDA 21 CFR Part 11 in the United States, EU Annex 11 in Europe, ISO 13485, and cGMP, continues to increase. At the same time, conventional operations based on paper and legacy systems have resulted in transcription errors and significant workloads for inspection and audit preparation. While implementing an eQMS is one way to address these challenges, such systems often require substantial upfront investment, and the cost of implementation and validation for computerized systems (CSV/GAMP 5) has also been a major hurdle.
Dot Compliance has been at the forefront of introducing its proprietary AI into QMS systems for medical products, bringing innovation to this field. It has enabled major enterprises to achieve significant improvements in operational efficiency, while also making QMS implementation more accessible and affordable for startups and small and medium-sized companies. Today, Dot Compliance has been adopted by more than 650 companies worldwide and has earned a high level of trust, including adoption by a Canadian regulatory authority. Through its collaboration with Dot Compliance, which provides a next-generation eQMS powered by advanced proprietary AI technology, Sanamedi will establish a comprehensive support framework covering everything from consideration of entry into the medical field and business expansion to the advancement and digitalization of QMS.
■ Key Features of Dot Compliance
Dot Compliance is an AI-powered eQMS purpose-built for the life sciences industry. Built directly on the Salesforce cloud platform, it offers strong reliability, security, and scalability, while facilitating integration with existing systems.
1. Industry-First Vertical AI “Dottie”
Going beyond a simple System of Record for data storage, Dottie AI transforms quality management into a “System of Action” that proactively supports real-time prediction, guidance, and audit readiness. Dot Compliance is certified to ISO/IEC 42001, the international standard for AI management systems, enabling secure and fully auditable AI operations.
2. Reduced Workload through Pre-Validated Validation Assets
Dot Compliance provides pre-validated validation assets aligned with 21 CFR Part 11 and GAMP 5, including a complete set of IQ/OQ/PQ documentation, as a standard offering. This reduces the need for complex customer-specific validation work and significantly reduces the workload for QA teams.
3. Centralized Global and Multilingual Quality Management
Core quality processes, including document management, complaint management and eMDR, audit management, and CAPA, can be managed centrally on a single platform. Dot Compliance has been adopted by regulatory authorities, including a Canadian regulatory authority, as well as by major medical device companies in Japan.
■ Future Initiatives
Leveraging the customer base and specialist network developed through its existing consulting business, Sanamedi will actively promote the adoption and use of Dot Compliance among medical device, biotechnology, regenerative medicine, medical software, and other companies in Japan. By providing end-to-end support from the creation of medical innovation through quality assurance and global regulatory compliance, Sanamedi aims to contribute to the development of Japan’s medical industry and strengthen its international competitiveness.
■ About Dot Compliance
Founder: Doron Sitbon
Head Office: Phoenix, Arizona, USA
Founded in 2015, Dot Compliance provides a ready-to-deploy, Salesforce-native eQMS with the industry’s first AI specifically built to deliver safe, reliable decision guidance for critical quality issues. This offers faster, more proactive quality and compliance through vertical AI that empowers data-driven decision making in life sciences quality and compliance.
Dot Compliance solutions are built in alignment with industry-leading standards and guidelines for computerized systems, including 21 CFR Part 11, EU Annex 11, and GAMP 5, empowering regulated companies to meet stringent requirements such as ISO 9001, ISO 13485, 21 CFR Part 820, cGMP, cGDP, GCP, and 21 CFR Parts 210/211.
Dot Compliance is certified to ISO 9001:2015 for Quality Management Systems, ISO/IEC 27001:2022 for Information Security Management Systems, ISO/IEC 27017:2015 for Cloud Security, and ISO/IEC 42001:2023 for AI Management Systems. These certifications underscore Dot Compliance’s commitment to delivering a secure, reliable software solution that supports customers in meeting their unique regulatory requirements. For more information, visit www.dotcompliance.com.
■ Contact for Inquiries
Public Relations, Sanamedi Inc.
TEL: 03-6262-3322 / FAX: 03-6262-3022
Email: info@sanamedi.com
