| |
|
|---|
OTHER REGULATORY CONSULTANCY
A. Country Registration:
Global market access support for device registrations in multiple countries including Asia, Latin America, Middle East, and other regions.
B. MDSAP:
Implementation and maintenance of Quality Management Systems compliant with Medical Device Single Audit Program requirements for multiple market access.
C. Annual Maintenance Contract:
Ongoing regulatory support through annual maintenance contracts covering all regulatory activities, updates, and compliance monitoring.
D. MANAGEMENT REVIEW MEETING REPORT:
Preparation of comprehensive management review reports that provide executive oversight of quality system performance and regulatory compliance.
E. Internal Quality Audit:
Conducting internal quality audits to assess QMS effectiveness, identify improvement opportunities, and ensure ongoing regulatory compliance.
F. Training:
Customized training programs on regulatory requirements, quality systems, and specific technical topics for your organization's needs.
G. Validation:
Comprehensive validation services for processes, software, and equipment to ensure compliance with regulatory requirements and quality standards.
H. ISO 13485 Consultants:
Expert consultancy for ISO 13485:2016 implementation, certification, and maintenance, ensuring robust quality management systems.