Electronic Quality Management System (eQMS)
Introduction
Electronic Quality Management System (eQMS)
We specialise in helping organisations implement and maintain ISO 13485:2016 Quality Management Systems (QMS) tailored for the medical device and diagnostic industry.
Achieving ISO 13485 certification is not just a regulatory requirement; it’s a testament to your commitment to quality and patient safety. Let us be your trusted partner on the journey to ISO 13485 compliance and beyond.
experience
Why Choose BaxMed for eQMS?
Expertise
Our team consists of eQMS experts with extensive experience in the Medical Device and In Vitro Diagnostics industry. We understand the unique challenges you face in managing quality processes.
Customised Solutions
We recognise that each organisation is unique. Our eQMS approach is highly adaptable, tailored to your specific quality objectives, processes, compliance requirements and budget.
Technology Driven
We leverage cutting-edge technology to provide you with a state-of-the-art eQMS solution that simplifies document control, training, audit management, and more.
Services
Our Comprehensive eQMS Services Include:
System Selection and Implementation: We help you select the right eQMS software for your organisation and ensure a seamless implementation process. We have solutions for the budget conscious startup to SME’s to large organisations.
Custom Configuration: Our experts configure the eQMS to align with your organisation’s unique quality processes, workflows, and reporting requirements.
Training and User Adoption: We provide comprehensive training to your team to ensure they are proficient in using the eQMS, fostering user adoption and maximising its benefits.
Document Control: Streamline document management, version control, and electronic signatures to ensure compliance with regulatory standards.
Training Management: Easily manage and track employee training records, certifications, and competencies, ensuring a well-trained workforce.
Audit Management: Facilitate efficient audit planning, execution, and tracking, helping you stay prepared for regulatory audits.
Non-Conformance Management: Identify and manage non-conformances efficiently, driving root cause analysis and corrective action.
CAPA (Corrective and Preventive Action) Management: Implement and monitor CAPA processes to address issues, prevent recurrence, and drive continuous improvement.
Trusted
Partner with BaxMed for Quality Excellence
Effective quality management is the cornerstone of success in the Medical Device and In Vitro Diagnostics industry. BaxMed’s eQMS services are designed to empower your organisation with the tools and processes needed to maintain the highest quality standards.
Choose BaxMed as your trusted partner in eQMS. Contact us today to discuss how our services can transform your quality management processes. Together, we’ll harness the power of technology to enhance compliance, drive efficiency, and ensure your organisation’s success in a highly regulated environment.
Contact
Get in touch
Contact us today to learn more about how BaxMed Regulatory Ltd can empower your organisation to thrive in a highly regulated environment. Together, we can turn regulatory and quality challenges into opportunities for growth and innovation.