Regulatory services
Regulatory Services for Medical Device Industries
DD Global MedDev provides expert regulatory support for all phases of global medical device development. We support regulatory registration activities in the USA, European Union, as well as the emerging Asia Pacific, Latin American, Central, and Eastern European markets. Regulatory Services include support of medical device product development, evaluation of changes to on-market medical devices, as well as regulatory activities related to mergers and acquisitions.
Not sure of your strategy? We provide full regulatory strategies outlining registration requirements that include clinical for specific global markets. We provide assistance with safety reporting requirements in Europe, Canada, Australia and United States. Does your organization need assistance with complaint handling due to lack of resources to handle large volume of complaints and reduce the overwhelming backlog? DDGlobal steps in to provide critical support by evaluating product complaints in a timely manner and complete reporting requirements according to global regulatory vigilance reporting requirements.
Regulatory services
- EU Submissions & Registrations
- Global product submissions and registrations
- 510 (k), PMA Submissions
- Recalls, Field Corrections & Safety Alerts
- Post Market Surveillance and Reporting
- Monitoring of North American & European Union Regulatory Activities
- Regulatory Strategy for new product development
- New Product Determinations/Classifications – Device Combinations
- Training & Education
- Product Complaint Analysis
- Change evaluations to determine impact to global submissions
- Quality System Auditing (ISO 13485)
- Risk Analysis