ZiMedical

                              Regulatory Affairs Consultants for Medical Device and IVD                                                                              Get a Free Consultation Today!                                            

Services We Provide and Markets We Support


Medical Device Registration


  • Assessment and execution of 510K and other submissions, assessments
  • Regulatory Strategy
  • Management / Leadership
  • Interface with Regulatory Agencies
  • Recalls & Complaint Analysis

Quality Management


  • QMS Development & Ownership
  • Design Assurance
  • Risk Management
  • Post-market surveillance
  • Recalls & Complaint Analysis
  • Assess design changes to  regulatory approach
U.S. FDA Agent
Other Services:

  • Compliance & Enforcement
  • Product Development
  • Local Agent Representation
  • Regulatory Information Technology Systems Selection & Implementation
  • Global Program and Project Management (Pharma and Device)


Your First Call is Free

Understanding regulatory systems in emerging markets goes beyond reading regulations, by doing, through each registration, each product testing, and each consultation with officials and reviewers. Take advantage of our experiences and gain your regulatory approval the RIGHT way.

Contact

Latest posts in our blog

Regulatory Assessment SaMD US/EU

01/21/2021

The Customer is a US based software company who recently involved in medical device industry to develop software for clinical study and patient enhanced experiences. They are seeking a quality and regulatory consultation support for FDA and CE compliance while they developing variety for software to be used either alone or in conjunction with other...

(206) 981-0675

mingzi@zi-medical.com (mandarin speaker)

Facebook

Twitter

Be the first to read what's new! Subscribe to our Newsletter