Unplex® Custom GPTs for innovators

Purpose-built assistants for quality/regulatory, SaMD engineering, clinical evaluation, and high-signal writing— designed for fast, structured outputs and easy review. Each GPT starts by clarifying scope, then produces checklists, workflows, and drafts you can validate inside your QMS.

Note: Outputs are decision-support content. Always verify against current regulations/standards and your internal procedures.

Custom GPTs

6 assistants • built for regulated, technical teams

Unplex® Medical Device Regulatory

A precision-engineered regulatory copilot for global medical device compliance across 10+ jurisdictions. Built on an ISO 13485:2016 foundation, with a process-approach mindset for audit-ready reasoning. Guides decisions across FDA, EU MDR, CDSCO, TGA, PMDA, Health Canada (MDSAP), and IMDRF frameworks. Turns vague requirements into structured actions: checklists, gap reviews, and review questions. Helps align QMS processes, technical documentation, and submission planning into one workflow. Designed to be conservative: clarifies assumptions, flags uncertainty, and prompts expert validation.

Unplex® SaMD

An interactive SaMD QA/RA/engineering copilot for regulated software development and release readiness. Anchors responses to ISO/IEC standards and maps guidance to evidence, traceability, and reviews. Asks clarifying questions first—so outputs match your intended use, architecture, and risk context. Transforms requirements into practical artifacts: verification planning, traceability prompts, and audits. Supports software, AI, cybersecurity, and data-regulation awareness with up-to-date searching capability. Optimized for teams who need clarity, structure, and defensible documentation workflows.

Unplex® Medical Devices CER

An EU MDR-focused Clinical Evaluation GPT to support CEP/CER drafting and evidence appraisal. Runs structured literature-review workflows and keeps claims tightly linked to documented evidence. Maps device claims to EI-cited proof, highlights gaps, and suggests what additional evidence is needed. Connects Clinical Evaluation with PMS/PMCF logic to strengthen lifecycle justification. Prompts Notified Body readiness checks—format, coverage, and rationale consistency. Built to avoid fabrication: it prioritizes traceability and flags missing or unsupported inputs.

Unplex® MedTechEdge

A LinkedIn content generator tailored for medical device companies and regulated-tech audiences. Converts technical work into clear, executive-friendly posts without losing compliance discipline. Helps shape hooks, structure, and key takeaways for fast-scanning professional readers. Supports repeatable formats: explainers, checklists, myth-vs-fact, and "how we do it" narratives. Designed to keep tone credible—technical, precise, and aligned with industry expectations. Ideal for founders and teams building visibility while staying grounded in real engineering work.

Unplex® Nonfiction Storytelling

A writing companion for narrative journalism–style creative nonfiction. Helps you find a strong angle, build a narrative arc, and structure scenes with intention. Guides voice, pacing, and transitions—so technical or real-world topics read with momentum. Supports drafting and revision with targeted prompts, not generic "write better" advice. Encourages clarity and factual discipline while improving readability and emotional pull. Best for founders, operators, and technical professionals writing story-driven longform.

Unplex® Literature

A reading companion for deep literary analysis and close reading. Explores themes, symbols, motifs, intertextuality, and narrative technique with academic rigor. Helps connect passages to context, structure, and argument—without flattening ambiguity. Supports annotations, discussion prompts, and interpretation frameworks for teaching or study. Encourages evidence-based reading: claims anchored to text, not vague impressions. Ideal for readers who want depth, not summaries.