Medical Device QMS
MDQMS is a quality System focusing on Medical Device design, manufacturing, and service provision per ISO13485.
Rigorous risk management ensures
Compliance with regulatory requirements
.svg)
Key Considerations
Medical Device manufacturer which is certified to ISO 13485 will gain access to the market and compete with competitors, regional market requirements. ISO 13485 QMS demonstrates the commitment to relevant interested parties including customer to shows the Quality is the core of the business. ISO 13485 QMS demonstrates compliance with relevant regulatory requirements such as FDA (USA), CE (Europe), TGA (Australia) etc. ISO 13485 certification provides Verification of the conformance to ISO requirements as well as applicable Regulatory requirements as defined in the QMS.
IntegPro designs and builds QMS processes as per ISO 13485 and regulatory requirement with the concept of Plan-Do-Check-Act cycle. The system can be designed traditional paper based or fully robust eQMS by using trusted and verified eQMS Software. The service includes Document Management, Training Management, Quality Event Management, CAPA Management, Change Management, Complaint Management, Audit Management, Supplier Quality Management, Risk Management, Design Control, Deviations/Non-conformances.
What is Medical Device Quality Management System (MDQMS)?
Medical Device Quality management System (MDQMS) is a Quality System which focuses on the Medical Device design, manufacturing, service provision as per ISO 13485. the Medical Device QMS provides an assurance program to Company and medical industry ensure the product has been made to the high quality standard and all relevant regulatory compliances are met
IntegPro’s ISO 13485 consultants:
IntegPro has competent experts who can design and implement ISO 13485 QMS step by step including:
- define the Scope,
- design processes and QMS Structure,
- develop QMS Documentations Including Quality Manual, Quality Policy, Quality Procedures, etc.,
- train processes owners,
- implement the processes and create records,
- conduct internal audits and management reviews,
- monitor Non Conformities, Corrective Actions Preventative Actions (CAPA),
- support during ISO 13485 certification Audits.
Join Other Industry Leaders
Companies utilising this solution.
Nova Eyes
Typical Project Timeline
.jpg)
Assessment Process
IntegPro follows a comprehensive assessment process to evaluate your organization's readiness for ISO certification.
Documentation
Our team assists in developing and implementing the necessary documentation for ISO compliance.
Training
We provide training sessions to educate your staff on ISO standards and best practices.
Internal Audits & Maintenance
Regular internal audits are conducted to identify areas for improvement and ensure ongoing compliance.
Book an Initial Consult
Simplify the complexity of compliance with a free initial consultation with IntegPro's skilled consultants to guarantee your firm is following the right procedures.
Common Questions
Find answers to commonly asked questions about ISO consulting and the certification process.
ISO certification is a globally recognized standard that ensures organizations meet certain requirements for quality, safety, and environmental management systems. It demonstrates a commitment to continuous improvement and compliance with industry regulations.
ISO certification is important for businesses as it enhances their credibility, improves customer trust, and opens up new opportunities in highly regulated industries. It also helps organizations streamline their processes and improve overall efficiency.
The duration of ISO certification depends on various factors, including the size and complexity of the organization, the readiness of existing management systems, and the chosen certification body. It typically takes several months to complete the certification process.
ISO consulting involves working with experienced professionals who provide guidance and support throughout the ISO certification journey. They help organizations develop and implement effective management systems, conduct internal audits, and prepare for external audits.
The cost of ISO consulting services can vary depending on the scope of work, the complexity of the organization's processes, and the level of support required. It is best to contact us for a tailored quote based on your specific needs.