{"name":"MDRpilot","category":"AI-assisted medical device regulatory software","tagline":"Make your MDR technical file audit-ready.","summary":"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.","disclaimer":"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.","url":"https://mdrpilot.com","lastUpdated":"2026-10-05","company":{"legalName":"NAVİCORE TEKNOLOJİ VE YAZILIM LİMİTED ŞİRKETİ","address":"Çamtepe Mah. Mahmut Tevfik Atay Blv. Gaziantep Teknopark No: 4 C İç Kapı No: 31 Şahinbey / Gaziantep","country":"TR","emails":{"sales":"sales@mdrpilot.com","support":"support@mdrpilot.com","privacy":"privacy@mdrpilot.com"}},"deployment":"Web application (SaaS)","targetUsers":["Medical device manufacturers preparing or maintaining EU MDR technical documentation","Regulatory affairs and quality assurance teams","Small and medium-sized manufacturers without a large in-house regulatory department","Regulatory consultants who manage several client files","Persons responsible for regulatory compliance (PRRC) who need an overview of open gaps"],"frameworks":["EU MDR 2017/745 (Regulation (EU) 2017/745 on medical devices)","ISO 13485:2016 quality management systems","ISO 14971:2019 risk management","MDCG guidance structures for clinical evaluation, PMCF and PSUR","Referenced standards tracked per product, e.g. ISO 10993, ISO 11607, ISO 11135, IEC 62304, IEC 62366-1"],"outOfScope":["IVDR (Regulation (EU) 2017/746) in vitro diagnostic devices","Direct submission to EUDAMED (UDI device data can be exported for manual preparation)","Registration tracking for non-EU markets","Supplier-provided validated computer system packages"],"workflow":["Requirements","Evidence","Documents","Risk","Clinical","PMS","QMS","Audit"],"modules":[{"id":"technical-file","name":"MDR technical documentation","summary":"Product-level technical file structured along MDR Annex II and Annex III, with section status (missing, draft, approved), AI-assisted drafts, manual editing and evidence attachments.","url":"https://mdrpilot.com/technical-file-software"},{"id":"classification","name":"Annex VIII classification assistant","summary":"Question-based helper that suggests a device class and the applicable Annex VIII rule with a written rationale. The manufacturer confirms the class.","url":"https://mdrpilot.com/mdr-technical-documentation"},{"id":"gspr","name":"GSPR checklist and evidence matrix","summary":"Annex I General Safety and Performance Requirements with applicability, justification for non-applicable items, linked standards and linked evidence files.","url":"https://mdrpilot.com/gspr-compliance"},{"id":"risk","name":"ISO 14971 risk management file","summary":"Risk management plan, hazard analysis and FMEA-style risk items with risk controls and verification of control effectiveness.","url":"https://mdrpilot.com/iso-14971-software"},{"id":"clinical","name":"Clinical evaluation","summary":"Clinical evaluation plan and report structure, literature search in PubMed and Europe PMC with PRISMA-style screening counts, equivalence data, a clinical gap matrix and a review and approval step.","url":"https://mdrpilot.com/clinical-evaluation-software"},{"id":"pms","name":"Post-market surveillance","summary":"PMS plan, PMCF plan and survey, and PSUR or PMS report outlines based on device class, connected to complaints and CAPA records.","url":"https://mdrpilot.com/pms-pmcf-software"},{"id":"design-control","name":"Design control traceability","summary":"Design input, output, review, verification, validation and transfer records with a traceability matrix (ISO 13485 clause 7.3) that can reference risk and clinical items.","url":"https://mdrpilot.com/medical-device-qms"},{"id":"ifu","name":"Instructions for use","summary":"IFU drafting from product data, structured around the information supplied with the device (MDR Annex I, Section 23).","url":"https://mdrpilot.com/technical-file-software"},{"id":"qms","name":"ISO 13485 QMS documentation","summary":"Quality manual wizard, procedures (SOPs), forms and instructions with document control, revision and approval workflow and a controlled document register.","url":"https://mdrpilot.com/iso-13485-software"},{"id":"operational","name":"Quality records","summary":"CAPA, complaints, internal audit, FSCA, vigilance, change control, management review, supplier evaluation, traceability, calibration and training matrix records.","url":"https://mdrpilot.com/capa-software"},{"id":"evidence","name":"Evidence files","summary":"Upload of test reports and other evidence; automated analysis suggests links to GSPR rows, risk controls and clinical evidence, which a user confirms before they are applied.","url":"https://mdrpilot.com/gspr-compliance"},{"id":"change-impact","name":"Change impact flags","summary":"When product data such as class, sterilisation or intended purpose changes, documents that depend on it are flagged for review.","url":"https://mdrpilot.com/mdr-gap-analysis"},{"id":"audit","name":"Audit readiness and audit simulator","summary":"Readiness score with a list of missing actions across technical file, QMS and CAPA, plus an audit simulator (MDR, ISO 13485, ISO 14971 or combined scope) that records findings as major, minor, observation or positive.","url":"https://mdrpilot.com/audit-readiness"},{"id":"exports","name":"Exports","summary":"Technical file DOCX and full ZIP, GSPR and risk XLSX, IFU DOCX, label PDF, PMS/PMCF DOCX, QMS package ZIP and document register XLSX, plus UDI device data XML for manual EUDAMED preparation.","url":"https://mdrpilot.com/technical-file-software"},{"id":"translator","name":"Document translator","summary":"Translation of regulatory documents between the supported languages with medical terminology handling.","url":"https://mdrpilot.com/regulatory-affairs-software"}],"ai":["AI drafting runs on the server; provider API keys never reach the browser.","When live AI is used, relevant excerpts are sent to configured AI providers (for example OpenAI or Anthropic) only to produce the requested output.","A company owner can turn off external AI processing for the whole workspace in Settings.","Without a live AI provider the platform runs on a deterministic built-in engine, so non-AI workflows keep working.","Controlled templates lock document headings; AI fills section bodies, and statements that cannot be confirmed from company data are marked [TO BE CONFIRMED] instead of being invented."],"interfaceLanguages":["tr","en","de","fr","es","it","nl"],"pricing":{"currency":"EUR","note":"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.","plans":[{"key":"starter","name":"Starter","monthlyPrice":0,"products":1,"seats":1,"summary":"Free. Document Studio access with starter credits; does not include the regulatory Suite."},{"key":"basic","name":"Basic","monthlyPrice":250,"products":1,"seats":1,"summary":"Suite access for 1 product and 1 seat, live AI and export center."},{"key":"plus","name":"Plus","monthlyPrice":450,"products":3,"seats":3,"summary":"Suite access for up to 3 products and 3 seats, live AI and export center."},{"key":"pro","name":"Pro","monthlyPrice":750,"products":5,"seats":5,"summary":"Suite access for up to 5 products and 5 seats, live AI and export center."},{"key":"enterprise","name":"Enterprise","monthlyPrice":null,"products":null,"seats":null,"summary":"Custom limits and terms. Contact sales."}]},"links":{"product":"https://mdrpilot.com/product","security":"https://mdrpilot.com/security","demo":"https://mdrpilot.com/register?intent=demo","resources":"https://mdrpilot.com/resources","glossary":"https://mdrpilot.com/glossary","llms":"https://mdrpilot.com/llms.txt","llmsFull":"https://mdrpilot.com/llms-full.txt","sitemap":"https://mdrpilot.com/sitemap.xml"}}