Don't forget to renew your FDA Registry & Listing before the end of the year! Click here for more.
RQMIS
Menu
Path to Market
Path to Market
Define Product
Design Product
Manufacture Your Product
Post Market Clinical Follow Up
Improve Product
Services
Services
Administration
Regulatory
Quality Management
Clinical
Postmarket Surveillance Service (PMSS)
Postmarket Surveillance Service
Cybersecurity in Medical Devices
Make a Cybersecurity Testing and Postmarket Surveillance Plan for Your Medical Device
US Agent Services (FDA Official Correspondent)
Medical Device Authorized Representative - EU Authorized Representative (EUAR) and UK Responsible Person (UKRP)
European Medical Device Authorized Representative for Medical Devices (EU Authorized Representative)
UK responsible person for Medical Devices /UK Medical Devices Authorized Representative
License & Certification for Medical Use Cannabis
Additional Services
Case Studies
Case Studies
Cybersecurity Requirements for Software Medical Devices: United States, Canada, European Union, and United Kingdom
RQMIS Supports the US ARMY in Gaining FDA clearance of APPRAISE-HRI
510(k) FDA Submission Repair
Startup success in an FDA Clearance
Clinical Study Repair
Combination Product Clearance
Implementing Post Market Clinical Study
Complaint Handling for Japanese Medical Device Manufacturer
Regulatory Strategy for FDA Warning Letter
View More Successes
Blog
About
About
Locations
RQMIS’s Collaborative Partnerships & Memberships
Events
Join our RQMIS team
Legal & Privacy
Contact
Additional Services
Dietary supplement audits
Adverse event reporting
Recalls
Corrective and Preventive Action (CAPA)
Integrating quality systems and regulatory submissions
Risk management system design
Managing risk
Vigilance, Medical Device Reporting (MDR) (21CFR803)
Training (risk management, ISO13485, 21CFR820, etc.)
Temporary regulatory, clinical, and quality management support
Design/hire regulatory, clinical, and quality department
Business acquisition/due diligence