LegalTech Inc. Launches 'DD Document Disclosure Management Workflow' for Medical Device M&A [LegalTech VDR]

LegalTech Inc. (Minato-ku, Tokyo; President and CEO: Tomoyuki Hirai) has announced the launch of a 'DD Document Disclosure Management Workflow' tailored for the medical device industry’s M&A and due diligence (DD) processes, available exclusively to clients using LegalTech VDR.

This workflow is a practical framework designed to properly classify, disclose, and manage confidential information—such as regulatory, quality assurance, technical, contractual, and financial documents—generated during medical device M&A, based on stakeholder roles. It supports the resolution of common operational challenges in DD, such as difficulty tracking who has accessed which documents, uncertainty about the location of the latest document versions, and repetitive responses to similar inquiries.

【Background】

In medical device M&A, cross-departmental document management and multi-layered disclosure controls present significant challenges.

Due diligence in medical device M&A extends beyond standard financial and legal reviews. It requires verification across multiple specialized domains, including regulatory approvals, Quality Management Systems (QMS), manufacturing outsourcing agreements, distribution contracts, intellectual property, and safety evaluations.

These documents are often managed separately by departments such as regulatory affairs, quality assurance, R&D, legal, and finance. As a result, inquiries tend to concentrate on these departments once DD begins.

Verifying the latest approval documents, locating QMS audit records, and collecting contracts can consume considerable time and effort.

Moreover, the scope of documents requiring review varies by stakeholder—such as buyer candidates, financial advisors (FA), lawyers, accountants, regulatory specialists, and quality assurance experts. While disclosure scope must be customized per buyer, traditional methods relying on email and file sharing make it difficult to manage who accessed which documents and when.

Consequently, operations often revert to using Excel for disclosure tracking, sending documents via email, and repeatedly handling document updates—making the DD process itself a significant operational burden.

To address these challenges, LegalTech Inc. has launched the 'DD Document Disclosure Management Workflow' for medical device M&A.

【Key Components of the DD Document Disclosure Management Workflow】

- Document Classification: Organize documents into categories such as regulatory, quality assurance, technical, contractual, financial, HR, and intellectual property.
- Disclosure Stage Management: Define disclosure scope by phase—initial screening, preliminary DD, detailed DD, and final negotiation.
- Access Control Design: Set viewing permissions tailored to buyer candidates, FAs, lawyers, accountants, regulatory specialists, and QA experts.
- Access Log Monitoring: Record and verify viewing activity for critical documents, maintaining a formal disclosure history.
- Q&A Management: Link questions and answers during DD to relevant documents for systematic organization.
- Version and Replacement Management: Track the status of updated and revised documents.
- Status Management: Visualize the disclosure status of each document.

This workflow systematically organizes practical tasks—from pre-DD document preparation to phased disclosure, Q&A handling, and document replacement management.

【Key Document Categories】

- Regulatory Documents: Approval and certification materials, notification documents, package inserts, regulatory correspondence history.
- Quality Assurance Documents: QMS-related documents, incident reports, CAPA records, audit logs.
- Technical Documents: Product specifications, design and development records, test data, manufacturing process documentation.
- Contractual Documents: Manufacturing outsourcing agreements, distribution agreements, joint development agreements, licensing agreements.
- Intellectual Property Documents: Patents, trademarks, design rights, know-how management records.
- Financial and Management Documents: Financial statements, business plans, customer information, organizational charts.
- HR Documents: Executive profiles, employment contracts, organizational structure.

【Target Use Cases】

- Share or business transfers of medical device manufacturers.
- M&A or capital alliances involving medical device startups.
- Business acquisitions involving manufacturing and marketing approvals.
- Overseas companies considering the acquisition of Japanese firms.
- Technical DD involving regulatory and quality documentation.
- Transactions where multiple buyer candidates conduct DD in parallel.
- Cases where additional disclosures or document replacements occur during the DD period.

【Support via LegalTech VDR】

This workflow is provided exclusively to LegalTech VDR clients and standardizes practical aspects of DD document management in medical device M&A, including classification, disclosure scope, access permissions, and disclosure status tracking.

LegalTech VDR is a virtual data room platform designed to support secure sharing and information control of confidential documents during M&A and due diligence. When combined with this workflow, it enables standardization of document management and disclosure operations.

Product Page: https://www.vdrs.jp

Inquiry: https://form.legaltech.co.jp/aos/legaltechvdr/input/

【Future Developments】

LegalTech Inc. plans to expand this offering beyond medical device M&A, gradually introducing industry- and use-case-specific workflows and templates for pharmaceuticals and biotech, chemicals and materials, semiconductors and electronic components, food and cosmetics, real estate and construction, and finance and funds.

Beyond M&A and DD, the company will continue developing support solutions for corporate document management, information sharing, and decision-making in areas such as fundraising, IPO preparation, audits and internal controls, joint research, and licensing negotiations.

【Company Overview】

- Company Name: LegalTech Inc.
- Established: March 2021
- Capital: ¥379 million (including capital reserves)
- President and CEO: Tomoyuki Hirai
- Address: 4F, Toranomon 40MT Building, 5-13-1 Toranomon, Minato-ku, Tokyo
- URL: https://www.legaltech.co.jp/

Business Overview:
LegalTech Inc. develops and provides the patent AI agent 'MyTokkyo.Ai,' the AI platform 'IPGenius,' and the confidential information platform 'LegalTech VDR.'