Does this skill include automated compliance tools?

The skill includes specialized scripts for automated submission status monitoring, compliance verification, and project timeline management.

How does this skill assist with FDA submissions?

It provides specialized guides and checklists for various FDA pathways, including 510(k), De Novo, and PMA, ensuring technical requirements and documentation standards are met.

Is this suitable for early-stage HealthTech startups?

Absolutely. It provides a strategic framework for regulatory pathway analysis, helping startups plan their market access timelines and resource allocation from day one.

Can it help with EU MDR 2017/745 compliance?

Yes, the skill includes specific submission guides and reference materials designed to navigate the European Medical Device Regulation requirements and technical file preparation.

Regulatory Affairs Head

Name: Regulatory Affairs Head
Author: alirezarezvani

byalirezarezvani

•

1,039

生产力与工作流

Provides expert-level leadership and strategic guidance for HealthTech and MedTech regulatory submissions and global compliance management.

关于

This skill transforms Claude into a Senior Regulatory Affairs Manager capable of navigating the complex global landscapes of FDA, EU MDR, and ISO certifications. It provides structured frameworks for regulatory pathway analysis, submission planning (De Novo, 510(k), PMA), and risk-benefit assessments, ensuring MedTech companies achieve market access efficiently while maintaining rigorous compliance standards. By integrating cross-functional leadership protocols and automated monitoring scripts, it helps teams coordinate complex submission workflows and mitigate regulatory risks throughout the product lifecycle.

主要功能

Structured risk assessment and mitigation frameworks for medical devices
Comprehensive submission management from pre-submission to post-market surveillance
1,039 GitHub stars
Strategic regulatory pathway analysis for FDA, EU MDR, and global markets
Automated compliance verification and submission tracking scripts
Cross-functional team coordination protocols and communication templates

使用场景

Determining the optimal regulatory pathway (e.g., 510(k) vs. De Novo) for a new medical device
Preparing structured documentation and checklists for EU MDR 2017/745 compliance
Establishing a standardized regulatory decision-making framework for HealthTech startups

关于

主要功能

Structured risk assessment and mitigation frameworks for medical devices
Comprehensive submission management from pre-submission to post-market surveillance
1,039 GitHub stars
Strategic regulatory pathway analysis for FDA, EU MDR, and global markets
Automated compliance verification and submission tracking scripts
Cross-functional team coordination protocols and communication templates

使用场景

Determining the optimal regulatory pathway (e.g., 510(k) vs. De Novo) for a new medical device
Preparing structured documentation and checklists for EU MDR 2017/745 compliance
Establishing a standardized regulatory decision-making framework for HealthTech startups