Medical Device MDR Auditorv1.0.0

A medical device manufacturer preparing for EU MDR certification uses this skill to audit their technical file before notifying a Notified Body. The skill checks for required documents like Clinical Evaluation Report (CER) and Post-Market Surveillance Plan (PMS), helping identify gaps early.

A quality assurance team conducts periodic internal audits of technical files for existing devices to ensure ongoing compliance with EU MDR 2017/745. The skill automates checklist verification, saving time and reducing human error.

A contract research organization (CRO) supporting a device manufacturer uses the skill to review PMS and PMCF documentation against regulatory requirements, ensuring completeness before a scheduled audit.

A small startup developing Class III medical devices uses this skill to self-audit their technical file and supply chain documentation before engaging a Notified Body for initial certification, reducing the risk of non-conformities.

A university or training institute uses the skill as a hands-on tool in regulatory affairs courses to teach students how to audit technical files against MDR requirements, with real-world examples from the references.

Offer a subscription-based cloud platform where medical device companies upload their technical files for automated MDR auditing. The skill runs checks in the background, generating compliance reports with actionable gaps.

Provide a one-time audit service where a regulatory expert manually reviews technical files with the skill's guidance. Deliver a detailed compliance report and remediation roadmap for a fixed fee per file.

License the skill as an API for integration into existing Quality Management Systems (QMS) like Greenlight Guru or MasterControl. Device manufacturers access the feature within their QMS for ongoing compliance checks.