Medical Device Regulatory Consulting

Proven Regulatory Strategies and Advice

Medical Device Regulatory Services

Market Entry

PMA Submissions / 510(k) Notifications
Global Medical Device Approval and Registration (ROW)
Device Registration and Listing
New Tech Files / Design Dossiers
CE Marking / European MDR Compliance
Health Canada CMDR Compliance and Licensing
Master File Preparation
U.S. Designated Agent for Foreign Manufacturers

Market Maintenance

Quality Management System Implementation/Maintenance
Regulatory gap assessments, quality system change/transition planning as regulations change
Post Launch Regulatory Support
Complaint Management / Adverse Event Reporting
Master File Maintenance
Tech Files / Design Dossier updates
Post Market surveillance

Remediation

FDA Warning Letter / 483 Support
FDA Consent Decree Support
CE Mark reinstatement

Data Management Compliance

HIPAA-Health Insurance Portability and Accountability Act
HITRUST-Security for Health Information Networks
GDPR-General Data Privacy Regulation
ISO27001 (Information Security)
Hazardous Materials (Various laws)

Help From Start to Finish

To achieve milestones effectively, you need medical device consulting services at several checkpoints along the process. By hiring us you’ll save precious time and money along the way.