Can this skill help determine medical device classification?

Yes, it includes decision frameworks and trees to help determine device risk levels (Class I, II, and III) under both FDA and EU MDR regulations.

Does it provide templates for regulatory documentation?

Yes, it includes structured templates for Regulatory Strategy documents, FDA/EU submission packages, and Regulatory Change Impact Assessments.

Which regulatory jurisdictions does this skill support?

The skill provides detailed workflows for the US (FDA) and European Union (MDR), while also covering market access strategies for Canada, Japan, China, Australia, and Brazil.

Is this skill useful for novel or high-risk devices?

Absolutely. It contains specific workflows for PMA and De Novo pathways in the US, as well as high-risk Class III clinical investigation requirements for the EU.

Regulatory Affairs Head

Name: Regulatory Affairs Head
Author: oabdelmaksoud

byoabdelmaksoud

0•

Productividad y Flujo de Trabajo

Accelerates HealthTech and MedTech market access with expert regulatory strategies, submission workflows, and global compliance frameworks.

This skill transforms Claude into a senior Regulatory Affairs expert, providing specialized guidance for medical device companies navigating complex global requirements. It offers comprehensive workflows for FDA submissions (510(k), PMA, De Novo), EU MDR compliance, and international market expansion strategies. By leveraging decision-making frameworks and standardized templates, it helps teams reduce submission risks, manage clinical evidence requirements, and maintain regulatory intelligence across shifting global landscapes.

Características Principales

01Global market access sequencing and localization strategy planning

02Regulatory intelligence monitoring and change impact assessment frameworks

030 GitHub stars

04Comprehensive EU MDR 2017/745 technical documentation and conformity guides

05Standardized FDA submission workflows including 510(k), PMA, and De Novo pathways

06Evidence-based decision trees for device classification and pathway selection

Casos de Uso

01Assessing the impact of new FDA or MDCG guidance on existing product portfolios

02Developing a multi-market regulatory strategy for a new Class II medical device

03Preparing documentation for a 510(k) submission or EU MDR Technical File

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add oabdelmaksoud/superclaw regulatory-affairs-head

For use in Claude.ai and ChatGPT

Características Principales

01Global market access sequencing and localization strategy planning

02Regulatory intelligence monitoring and change impact assessment frameworks

030 GitHub stars

04Comprehensive EU MDR 2017/745 technical documentation and conformity guides

05Standardized FDA submission workflows including 510(k), PMA, and De Novo pathways

06Evidence-based decision trees for device classification and pathway selection

Casos de Uso

01Assessing the impact of new FDA or MDCG guidance on existing product portfolios

02Developing a multi-market regulatory strategy for a new Class II medical device

03Preparing documentation for a 510(k) submission or EU MDR Technical File

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add oabdelmaksoud/superclaw regulatory-affairs-head

For use in Claude.ai and ChatGPT