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More than any other industrial segment, medical device manufacturers need to ensure the quality of their products because they deal with human safety. The accuracy and efficiency of the devices’ performance could well be a matter of life and death.

Moreover, the safety and proper performance of the device astronomically increase with each level of the Class that the device is categorized under. Class III device manufacturers are scrutinized more than that of Class II and Class II is scrutinized more than that of Class I.

Implementing quality best practices is essential for each manufacturer in more ways than one. An automated, highly integrated and next-generation, enterprise-wide quality management system such as the one provided by ComplianceQuest can provide deep insights that can go beyond quality assurance and help increase the efficiency and effectiveness of the medical device manufacturer’s operations and processes.

Successful implementation of quality best practices for medical device companies requires a simple 7-Step approach

  • Understand the regulatory landscape
  • Design your Quality & Compliance process
  • Benchmark against Industry Best Practices
  • Design standard operating procedures
  • Create a master quality and regulatory checklist
  • Quality analytics to derive insights from Quality data
  • Continuous improvement

“We have implemented CQ in a new medical device startup. The setup and implementation went very smooth and the support from the provider has been outstanding. The system fully supports compliance with ISO 13485.
Some of the reasons why I would recommend the software are:

  • 100% cloud-based
  • Allow almost paperless Quality Management System
  • Excellent customer support
  • Simple set up and implementation
  • User friendly
  • Efficiency and security
  • Accessible cost for small companies.”

Laura Granados, QMS Systems Development Consultants