ISO 13485:2003,"Medical devices " Quality management systems "Requirements for regulatory purposes", is a quality system which was specially designed for use in the medical device industry. Qserve Consultancy's team of quality management systems experts and certified Lead Auditors can implement and maintain ISO 13485 for your company. Qserve Consultancy offers a customized service, tailored to your needs.

Implementation

• GAP analysis
• implementation ISO 13485, Quality Management System, Quality Systems Regulations (QSR), and CMDCAS
• Advice on and assistance with your quality management organization
• Advice on and assistance with preparing your quality manual and umbrella procedures
• Compilation of documentation and help with the certification process (third party audit)
• Validation services: Installation Validation (IQ), Operational Validation (OQ) and Performance Validations (PQ) in relation to products, design control, and processes

Maintenance

• Advice on and assistance with the maintenance of quality management systems in compliance with applicable standards EN ISO 13485, QSR/FDA and CAN/CSA 13485 and national and international regulations
• Advice on and assistance with management control of QMS and regulatory compliance
• Advice on and assistance with specific process elements, e.g., design control, validation processes and products, purchasing, complaint handling, etc.

For more information, please download our flyer:quality systems_eng.pdf

Qserve Consultancy offers various courses and training in the above.
For more information please click on Training.