ISO 13485 & GDPMD Implementation
Comprehensive Quality Management System Solutions
Building and maintaining compliant quality management systems is essential for medical device manufacturers. Our ISO 13485 and GDPMD implementation services provide end-to-end support, from initial gap assessment through certification and continuous improvement.
Our accredited programs help organizations develop robust quality frameworks that satisfy regulatory requirements while enhancing operational efficiency.
We specialize in:
- Designing QMS structures aligned with ISO 13485:2016
requirements - Implementing Good Distribution Practice for Medical Devices
(GDPMD) systems for Singapore market access - Conducting pre-certification audits to ensure readiness
- Training internal auditors to maintain ongoing compliance
Our implementation approach emphasizes practical, sustainable systems that work for your organization’s size and complexity. We focus on creating documentation and processes that add real value rather than unnecessary bureaucracy, helping you achieve certification with minimum disruption.
Medical Device & Technical File Preparation
Comprehensive Documentation Assessment
We conduct thorough reviews of existing documentation against current regulatory requirements, identifying gaps and opportunities for improvement. Our experts ensure your technical documentation meets the latest standards for ISO compliance, GDPMD, and MDR submissions
Technical File Development & Compilation
Our team assists in preparing all components of your medical device technical file, from device descriptions and manufacturing processes to clinical evaluations and risk management reports. We ensure information is presented clearly and comprehensively to facilitate regulatory review
Pre-Submission Verification
Before regulatory submission, we conduct thorough verification checks to ensure all documentation is complete, consistent, and compliant with the latest regulatory standards. This minimizes requests for additional information and helps prevent submission delays.
Our technical file preparation services help manufacturers navigate complex documentation requirements with confidence. We understand that proper documentation is not just about compliance4it’s about creating a comprehensive knowledge base that supports your product throughout its lifecycle and facilitates efficient regulatory reviews worldwide.
