# MDRpilot

> Make your MDR technical file audit-ready. MDRpilot is an AI-assisted regulatory workspace for medical device manufacturers. It helps teams structure the EU MDR 2017/745 technical file, map GSPR evidence, maintain ISO 14971 risk files, prepare clinical evaluation and PMS/PMCF documentation, and run ISO 13485 quality records in one place, so gaps are visible before an audit.

MDRpilot is documentation and workflow software. It is not a medical device, not a notified body and not a regulatory authority. It does not certify devices or guarantee compliance; AI-generated drafts must be reviewed and approved by qualified people in the manufacturer's organisation.

Category: AI-assisted medical device regulatory software. Company: NAVİCORE TEKNOLOJİ VE YAZILIM LİMİTED ŞİRKETİ, Çamtepe Mah. Mahmut Tevfik Atay Blv. Gaziantep Teknopark No: 4 C İç Kapı No: 31 Şahinbey / Gaziantep. Contact: sales@mdrpilot.com (sales), support@mdrpilot.com (support).

## Product
- [Product profile](https://mdrpilot.com/product): company, category, modules, frameworks, languages, pricing
- [Security and data handling](https://mdrpilot.com/security)
- [Guided demo](https://mdrpilot.com/demo)
- [Pricing](https://mdrpilot.com/#pricing): Prices are listed in EUR per month. Annual billing charges 10 months for 12. A 3-day demo of the Suite can be requested at sign-up.

## Solutions
- [MDR software that keeps your technical file, evidence and quality records connected](https://mdrpilot.com/mdr-software): What MDR software does, who needs it and how MDRpilot connects technical documentation, GSPR, risk, clinical, PMS and QMS work in one regulatory workspace.
- [Software for the obligations in Regulation (EU) 2017/745](https://mdrpilot.com/eu-mdr-software): Software support for the obligations in Regulation (EU) 2017/745: Article 10 manufacturer duties, Annex I GSPR, Annex II/III documentation, clinical evaluation and PMS.
- [Technical file software for MDR devices](https://mdrpilot.com/technical-file-software): Build and maintain an MDR technical file per device: Annex II and III structure, section status, AI-assisted drafts, linked evidence and DOCX, PDF or ZIP export.
- [MDR technical documentation under Annex II and Annex III](https://mdrpilot.com/mdr-technical-documentation): What MDR Annex II and Annex III require in the technical documentation, section by section, and how each section is handled in MDRpilot.
- [GSPR compliance with evidence you can trace](https://mdrpilot.com/gspr-compliance): Map every MDR Annex I General Safety and Performance Requirement to applicability, standards and evidence, and see which GSPR rows are still unsupported.
- [ISO 14971 risk management software connected to your evidence](https://mdrpilot.com/iso-14971-software): Maintain an ISO 14971:2019 risk management file per device: plan, hazard analysis, risk controls, verification of controls and benefit-risk, linked to GSPR and PMS.
- [Clinical evaluation software for the CEP, literature and CER](https://mdrpilot.com/clinical-evaluation-software): Plan and document MDR clinical evaluation: CEP, literature search in PubMed and Europe PMC, equivalence, clinical gap matrix and CER with review and approval.
- [PMS and PMCF software that feeds back into risk and clinical evaluation](https://mdrpilot.com/pms-pmcf-software): Post-market surveillance under MDR Articles 83–86: PMS plan, PMCF plan and survey, PSUR or PMS report by device class, linked to complaints, CAPA and risk.
- [Medical device regulatory software: what the category covers](https://mdrpilot.com/medical-device-regulatory-software): How medical device regulatory software differs from eQMS, document management and spreadsheets, and where an AI-assisted regulatory workspace like MDRpilot fits.
- [ISO 13485 software for quality manuals, procedures and controlled records](https://mdrpilot.com/iso-13485-software): Build and run ISO 13485:2016 documentation: quality manual wizard, SOPs, forms, document control with review and approval, and a controlled document register.
- [A medical device QMS that is connected to your devices](https://mdrpilot.com/medical-device-qms): What a medical device quality management system must cover under MDR Article 10(9) and ISO 13485, and how it connects to technical documentation and PMS.
- [CAPA software that closes the loop with complaints, audits and risk](https://mdrpilot.com/capa-software): Run corrective and preventive actions under ISO 13485 clause 8.5: sources, root cause, actions, effectiveness checks and links to complaints, audits and risk.
- [Medical device compliance software for the whole device lifecycle](https://mdrpilot.com/medical-device-compliance-software): What compliance means for medical device manufacturers across the lifecycle, what software can and cannot do, and how MDRpilot keeps documentation and records consistent.
- [Audit readiness for MDR and ISO 13485 audits](https://mdrpilot.com/audit-readiness): Prepare for notified body and internal audits with a readiness score, a list of missing actions across technical file, QMS and CAPA, and an audit simulator.
- [MDR gap analysis that turns findings into actions](https://mdrpilot.com/mdr-gap-analysis): Find what is missing between your current documentation and EU MDR: GSPR evidence, clinical data, PMS, QMS procedures and change-related gaps, with clear next actions.
- [AI for medical device regulatory work, with guardrails](https://mdrpilot.com/ai-for-medical-device-regulatory): How AI can support medical device regulatory affairs without inventing facts: controlled templates, confirmed company facts, human approval and a workspace-level opt-out.
- [Regulatory affairs software for medical device teams](https://mdrpilot.com/regulatory-affairs-software): Tools for medical device regulatory affairs teams: classification rationale, technical file ownership, UDI data, translations and notified body readiness.

## Guides
- [What Is EU MDR 2017/745?](https://mdrpilot.com/resources/what-is-eu-mdr): A plain explanation of the EU Medical Device Regulation 2017/745: scope, key dates, classification, conformity assessment, economic operators and what changed from the MDD.
- [EU MDR Technical Documentation: Complete Guide](https://mdrpilot.com/resources/mdr-technical-documentation-guide): What EU MDR technical documentation is, who reviews it, how long to keep it, how it connects to the QMS and how to keep it current over the device lifecycle.
- [MDR Annex II and Annex III Explained](https://mdrpilot.com/resources/mdr-annex-ii-and-iii-explained): Section-by-section explanation of MDR Annex II (technical documentation) and Annex III (technical documentation on post-market surveillance), with what reviewers look for.
- [What Is GSPR Compliance?](https://mdrpilot.com/resources/what-is-gspr-compliance): What the General Safety and Performance Requirements are, how Annex I is organised, how to document GSPR compliance and the mistakes reviewers find most often.
- [How to Build an MDR Technical File](https://mdrpilot.com/resources/how-to-build-an-mdr-technical-file): A practical sequence for building an MDR technical file: intended purpose, classification, GSPR, risk, verification, clinical evaluation, labelling, PMS and final review.
- [MDR Gap Analysis Guide](https://mdrpilot.com/resources/mdr-gap-analysis-guide): How to run an MDR gap analysis on a technical file and QMS: scope, inputs, a structured review by Annex, prioritisation of findings and turning gaps into a plan.
- [Clinical Evaluation Report (CER) Guide](https://mdrpilot.com/resources/clinical-evaluation-report-guide): How to plan and write an MDR clinical evaluation report: CEP contents, data sources, literature search, appraisal, equivalence, sufficiency, PMCF and updates.
- [PMS and PMCF Explained](https://mdrpilot.com/resources/pms-and-pmcf-explained): Post-market surveillance and post-market clinical follow-up under the EU MDR: PMS system, PMS plan, PMS report and PSUR, PMCF plan and report, vigilance and trend reporting.
- [ISO 13485 for Medical Device Manufacturers](https://mdrpilot.com/resources/iso-13485-for-medical-device-manufacturers): What ISO 13485:2016 requires, how it differs from ISO 9001, how it relates to MDR Article 10(9), which documents you need and how certification works.
- [ISO 14971 Risk Management Guide](https://mdrpilot.com/resources/iso-14971-risk-management-guide): The ISO 14971:2019 risk management process step by step: plan, analysis, evaluation, control, overall residual risk, review and post-production, and how it maps to MDR Annex I.
- [MDR Audit Preparation Checklist](https://mdrpilot.com/resources/mdr-audit-preparation-checklist): A practical checklist for notified body QMS audits and technical documentation reviews under the EU MDR, including unannounced audits, records to have ready and how to rehearse.
- [Medical Device CAPA Guide](https://mdrpilot.com/resources/medical-device-capa-guide): How to run CAPA under ISO 13485 clause 8.5 and MDR: when to open a CAPA, root cause analysis, actions, verification, effectiveness checks and links to risk and PMS.
- [AI in Medical Device Regulatory Affairs](https://mdrpilot.com/resources/ai-in-medical-device-regulatory-affairs): Where AI genuinely helps regulatory affairs teams, where it creates risk, how to control AI-generated content in a QMS and what the EU AI Act does and does not cover.
- [MDR Technical Documentation Software Comparison](https://mdrpilot.com/resources/mdr-software-comparison): A neutral framework for comparing MDR technical documentation software: criteria, questions to ask vendors, a scoring template and what MDRpilot does and does not offer.
- [MDR Software for Small and Medium-Sized Medical Device Manufacturers](https://mdrpilot.com/resources/mdr-software-for-smes): What SMEs need from MDR software: small teams covering many roles, PRRC at disposal, limited budgets, consultant collaboration and a fast path from legacy files to MDR.

## Reference
- [Glossary](https://mdrpilot.com/glossary): MDR, IVDR, GSPR, CER, PMS, PMCF, PSUR, CAPA, QMS, ISO 13485, ISO 14971
- [MDR software: what to look for in 2026](https://mdrpilot.com/compare/mdr-software)
- [Ophthalmic Device Technical Documentation: An Illustrative Case Study](https://mdrpilot.com/case-studies/ophthalmic-medical-device): illustrative scenario, not a customer result
- [MDR Technical File Gap Analysis: An Illustrative Case Study](https://mdrpilot.com/case-studies/mdr-technical-file-gap-analysis): illustrative scenario, not a customer result
- [Building an ISO 13485 QMS: An Illustrative Case Study](https://mdrpilot.com/case-studies/iso-13485-qms): illustrative scenario, not a customer result

## Optional
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- [Distance sales agreement](https://mdrpilot.com/distance-sales)