FormlyAI
Provides a software-enabled regulatory compliance platform and managed services for medical device companies, combining AI assistance with regulatory experts to support CE marking, FDA pathways, QMS implementation, technical documentation, and ongoing post-market compliance.
Industries
Nr. of Employees
small (1-50)
Products
Document generator library (regulatory templates)
A library of prebuilt regulatory and quality templates (SOPs, plans, reports, checklists) that can be generated and completed to produce technical documentation and QMS artifacts.
Regulatory compliance platform (virtual regulatory officer)
A platform combining automation and human expertise to manage certification roadmaps, compliance workflows, multi-device registries, and ongoing surveillance.
Document generator library (regulatory templates)
A library of prebuilt regulatory and quality templates (SOPs, plans, reports, checklists) that can be generated and completed to produce technical documentation and QMS artifacts.
Regulatory compliance platform (virtual regulatory officer)
A platform combining automation and human expertise to manage certification roadmaps, compliance workflows, multi-device registries, and ongoing surveillance.
Services
Pre-Certification (Fixed Fee)
End-to-end regulatory support to prepare a device for market entry under a single fee, including regulatory strategy, technical documentation, QMS setup, and audit support.
Post-Certification (Annual Fee)
Ongoing compliance-as-a-service for maintained regulatory obligations after certification, including eQMS management, change assistance, complaint handling, periodic reports, and surveillance.
Regulatory consulting and expert support
Access to regulatory consultants and named experts to guide strategy, prepare submissions, and liaise with notified bodies or regulators.
Pre-Certification (Fixed Fee)
End-to-end regulatory support to prepare a device for market entry under a single fee, including regulatory strategy, technical documentation, QMS setup, and audit support.
Post-Certification (Annual Fee)
Ongoing compliance-as-a-service for maintained regulatory obligations after certification, including eQMS management, change assistance, complaint handling, periodic reports, and surveillance.
Regulatory consulting and expert support
Access to regulatory consultants and named experts to guide strategy, prepare submissions, and liaise with notified bodies or regulators.
Expertise Areas
- Regulatory compliance and CE marking
- FDA submissions (510(k), PMA) and US market entry
- Quality Management Systems (ISO 13485, QMSR) and eQMS
- Clinical evaluation and post-market clinical follow-up
Key Technologies
- AI-assisted document generation
- Digital eQMS
- Software development lifecycle tooling (IEC 62304)
- UDI management and EUDAMED data mapping