MedReg AI supports comprehensive regulatory gap analysis across the life sciences industry. Whether you're developing medical devices, pharmaceutical drugs, or dietary supplements, our AI-powered platform helps you navigate complex regulatory requirements with confidence.
Medical Device Regulations
EU MDR 2017/745
The European Medical Device Regulation (EU MDR) replaced the previous Medical Device Directive (MDD) and introduced stricter requirements for medical devices sold in the European Union.
Key Requirements We Analyze:
- General Safety and Performance Requirements (GSPR)
- Technical Documentation structure and content
- Clinical Evaluation Reports (CER)
- Post-Market Surveillance (PMS) plans
- Unique Device Identification (UDI) compliance
- Quality Management System alignment with ISO 13485
Who Needs EU MDR Compliance:
- Manufacturers selling medical devices in EU member states
- Authorized Representatives for non-EU manufacturers
- Importers and distributors of medical devices
FDA 510(k) Pre-Market Notification
The 510(k) pathway is the most common route to market for medical devices in the United States. It requires demonstrating that your device is substantially equivalent to a legally marketed predicate device.
Key Requirements We Analyze:
- Device description and intended use
- Substantial equivalence comparison
- Performance testing data
- Biocompatibility information
- Software documentation (for devices with software)
- Labeling and instructions for use
- Sterilization validation (if applicable)
Who Needs 510(k) Clearance:
- Class II medical device manufacturers
- Some Class I devices with special controls
- Devices making new claims requiring new clearance
Additional Medical Device Pathways
MedReg AI also supports:
- FDA PMA (Pre-Market Approval): For Class III high-risk devices
- FDA De Novo: For novel low-to-moderate risk devices without predicates
- EU IVDR: In Vitro Diagnostic Regulation for diagnostic devices
Pharmaceutical Regulations
NDA (New Drug Application)
The New Drug Application is the formal step a pharmaceutical company takes to request FDA approval to market a new drug in the United States.
Key Requirements We Analyze:
- Chemistry, Manufacturing, and Controls (CMC)
- Nonclinical pharmacology and toxicology studies
- Clinical trial data and statistical analysis
- Proposed labeling
- Patent and exclusivity information
- Risk Evaluation and Mitigation Strategies (REMS)
Who Needs NDA Approval:
- Pharmaceutical companies with new molecular entities
- Companies seeking approval for new indications
- Developers of new drug formulations
ANDA (Abbreviated New Drug Application)
The ANDA pathway allows generic drug manufacturers to obtain FDA approval without repeating costly clinical trials by demonstrating bioequivalence to an approved reference listed drug.
Key Requirements We Analyze:
- Bioequivalence studies
- Chemistry, Manufacturing, and Controls (CMC)
- Labeling that matches the reference listed drug
- Patent certifications (Paragraph I-IV)
- Facility compliance documentation
Who Needs ANDA Approval:
- Generic pharmaceutical manufacturers
- Companies developing authorized generics
- 505(b)(2) applicants (hybrid pathway)
Dietary Supplement Regulations
DSHEA (Dietary Supplement Health and Education Act)
DSHEA establishes the regulatory framework for dietary supplements in the United States, defining how supplements can be manufactured, labeled, and marketed.
Key Requirements We Analyze:
- Product labeling compliance (Supplement Facts panel)
- Structure/function claims substantiation
- Disclaimer requirements
- New Dietary Ingredient (NDI) notification requirements
- Adverse event reporting procedures
- Good Manufacturing Practice (GMP) alignment
21 CFR Part 111 (cGMP for Dietary Supplements)
Current Good Manufacturing Practice regulations ensure dietary supplements are produced consistently and meet quality standards.
Key Requirements We Analyze:
- Personnel qualifications and training
- Physical plant and grounds requirements
- Equipment and utensil specifications
- Production and process controls
- Laboratory operations
- Holding and distribution procedures
- Records and recordkeeping
Who Needs DSHEA/cGMP Compliance:
- Dietary supplement manufacturers
- Contract manufacturers and packagers
- Private label supplement brands
- Importers of dietary supplements
How MedReg AI Helps
Unified Gap Analysis Platform
Instead of using separate tools or consultants for each regulatory framework, MedReg AI provides a single platform that understands the nuances of each regulation:
- Select Your Product Type: Choose medical device, pharmaceutical, or dietary supplement
- Choose Target Regulations: Select applicable frameworks (EU MDR, 510(k), NDA, ANDA, DSHEA, etc.)
- Upload Documentation: Add your technical files, clinical data, and supporting documents
- Receive Comprehensive Analysis: Get detailed gap reports with specific requirement citations
Cross-Regulatory Intelligence
For companies with products spanning multiple categories or markets, MedReg AI identifies:
- Overlapping requirements across regulations
- Documentation that can serve multiple purposes
- Gaps that affect compliance in multiple jurisdictions
- Opportunities to streamline your regulatory strategy
Always Current
Regulatory requirements evolve constantly. MedReg AI stays updated with:
- FDA guidance document updates
- EU regulatory amendments
- New industry standards
- Emerging best practices
Getting Started
Ready to analyze your documentation against these regulatory frameworks?
- Create a Free Account - No credit card required
- Start a New Project - Select your regulations
- Upload Your Documents - Our AI handles the rest
- Review Your Gap Report - Get actionable compliance insights
Questions?
Our regulatory experts are here to help. Contact us to discuss your specific compliance needs or schedule a demo to see MedReg AI in action.
MedReg AI provides regulatory intelligence tools to assist with compliance analysis. Final regulatory decisions should be made in consultation with qualified regulatory affairs professionals.
