QMS Consulting Services
Professional Consulting Services for establishing a Quality Management System
(QMS)
for Software as a Medical Device (SaMD)
We create better medical software through the establishment of Innovative SaMD QMS.
Features
Services
1
Current State
Analysis and
GAP Analysis
We assess the current status of the operating system and analyze any discrepancies against international standards such as ISO 13485 and IEC 62304, as well as regulatory requirements.
2
QMS Strategy
and Roadmap
Development
We develop a customized QMS strategy aligned with the client's business objectives and product characteristics and provide a phased plan of execution.
3
Documentation
and Procedure
Establishment
We create essential documents for SaMD QMS, encompassing Quality Manual, Procedures, Work Instructions, and Templates to enhance operational exellence.
4
Education and
Training Programs
We offer education programs for all employees to ensure effective operation of the quality management system and support training for continuous improvement.
5
Internal Audit
and Certification
Preparation
We inspect the operational status of the QMS and perform mock audits to support the acquisition of certification.
Our Expertise
Understanding of Medical Device QMS
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Experience
Neurophet’s
Consulting Services
