Services Offered
MAVEN offers end-to-end regulatory services for medical devices and In-vitro Diagnostics:
Maven Expertise
- Labeling & Promotional Material Review
- Post Market Surveillance Support
- QMS Compliance Services
- Regulatory Compliance, Gap Analysis & Remediation
- Regulatory Intelligence
- Regulatory Strategy
- Regulatory Submission and Registration
- Multi Language Translation
- 510(k) Submission Process Consulting
- 513(g) Submission Process Consulting
- Clinical Evaluation Report (CER)
- Medical Devices Regulation (MDR)
- In Vitro Diagnostic Regulation (IVDR)
- Performance Evaluation Report (PER)
- Medical Device Technical File Compilation
- Medical Device Master File Compilation
Regional Guidance
US Region: MAVEN guides you in registering the device based on compulsory FDA approval procedures:
- Pre-market notification 510(k)
- Pre-market approval (PMA)
- 513(g) Applications
- De Novo Petition
- Establishment Registration and Device Listing
- Medical Device Gap Analysis
European Union: MAVEN aids in making the approval process easier and manages multi-lingual and complex regulations:
- Technical File Preparation and Submission
- CE Marking and Approvals
- ISO QMS Certification
- EU MDR Support
- Appointing Authorised Representative
Canada: MAVEN can accelerate device approval by obtaining necessary licences:
- Medical Device Establishment License (MDEL)
- Medical Device License (MDL)
