Regulatory Affairs Services
Global Regulatory Affairs Solutions for Medical Devices
With years of experience navigating the complex regulatory frameworks of leading authorities such as the FDA (USA), Health Canada (HC), EU MDR, MHRA (UK), ANVISA (Brazil), and SwissMedic (Switzerland), Global Medtech Solutions is your trusted partner in achieving successful medical device launches across the globe.
Comprehensive Regulatory Support for Medical Devices
Our expert team provides tailored Regulatory Affairs solutions designed to meet the unique requirements of each region, ensuring your medical devices reach the market efficiently and compliantly in:
- United States
- Canada
- Europe
- United Kingdom
- Brazil
- Pakistan
- Switzerland
Our Services Include
- Regulatory Strategy Development: Crafting market-specific regulatory roadmaps to streamline approval processes.
- Pre-Market Submissions: Preparing and submitting dossiers for FDA 510(k), PMA, CE Marking, Health Canada, ANVISA, and more.
- Technical Documentation: Developing compliant technical files, design dossiers, and labeling.
- Clinical Evaluation Reports (CER): Ensuring robust documentation to meet EU MDR requirements.
- Post-Market Surveillance: Providing guidance on vigilance reporting, updates, and compliance maintenance.
- Global Market Expansion: Assisting with product registration and licensing across multiple geographies.
- Clinical Evaluation Reports (CER): Ensuring robust documentation to meet EU MDR requirements.
- Post-Market Surveillance: Providing guidance on vigilance reporting, updates, and compliance maintenance.
- Global Market Expansion: Assisting with product registration and licensing across multiple geographies.