Lexis AI LaunchPad™ - Turkey:

Your Turnkey Market Entry Platform for Health AI Solutions

Turkey's dynamic and expanding healthcare ecosystem presents immense potential for artificial intelligence (AI) based technologies. However, translating this potential into reality requires navigating a multi-layered labyrinth of complex medical device regulations, stringent data protection laws, and unique legal challenges. As an international AI developer, will you spend your energy on innovation or on bureaucracy?

At Lexis.com.tr, we have designed Turkey's first and only integrated market entry solution to eliminate this challenge: Lexis AI LaunchPad™ - Turkey.

This service package is a comprehensive, three-module "turnkey" solution that manages the entire lifecycle of your AI health product, from concept to clinical deployment in Turkey, all from a single point of contact. Our mission is to transform legal and regulatory hurdles into stepping stones, enabling you to enter the market with maximum speed and security.

The Three Core Modules of the LaunchPad Package:

Module 1: Regulatory Gateway & TİTCK Compliance We manage the entire official approval process, starting from the classification of your AI solution as 'Software as a Medical Device (SaMD)'.

• CE & MDR Alignment: We ensure your technical file, clinical evaluation reports, and ISO 13485 Quality Management System for the CE mark under the EU's Medical Device Regulation (MDR) are fully aligned with Turkish requirements.

• TİTCK Registration & Authorized Representation: We complete your product registration with the Turkish Medicines and Medical Devices Agency (TİTCK) and, as a legal requirement, assume the role of 'Authorized Representative' or 'Importer' to manage your post-market surveillance and incident reporting obligations.

• Localization: We handle the translation and local adaptation of labeling and instructions for use into Turkish, ensuring full compliance.

Module 2: Commercial & Legal Structuring The right business model is the foundation of sustainable success. We secure your commercial objectives with our legal expertise.

• Business Model Strategy: We identify and establish the optimal legal framework for your goals, whether it's an exclusive agency, distributorship, joint venture (JV), or a localized SaaS licensing model.

• Contract Management: We draft and manage all stakeholder agreements (with hospitals, distributors, end-users) to minimize product liability and malpractice risks, while safeguarding your intellectual property. Contractual indemnity clauses and insurance requirements are central to this module.

Module 3: Data Integrity & KVKK Fortress In Turkey, health data is classified as 'special category personal data' and is protected at the highest level. The slightest error in this domain can lead to severe penalties and reputational damage.

• KVKK Compliance: We establish full compliance with the Turkish Personal Data Protection Law (KVKK), including setting up explicit consent mechanisms, managing VERBİS registration, and implementing procedures for data minimization and the 72-hour breach notification rule.

• Data Residency & Secure Transfer: Given the challenges of cross-border data transfer, we provide secure and legally compliant solutions for data residency within Turkey.

• Data Processing Agreements: For SaaS models, we draft clear, compliant agreements that define the roles and responsibilities between the data controller and data processor.

Step confidently into the Turkish market with the Lexis AI LaunchPad™. Let us manage the complexity, so you can focus on developing the future of healthcare.