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At ComplianceQuest, we’ve worked with 100+ customers in the medical device ecosystem, helping them adopt a next-generation EQMS for their quality management workflow.
Thanks to this experience, we believe the following 7-step approach will be really helpful for quality leaders at medical device companies, who’re just embarking on the digital transformation journey of their quality processes:

  • Step 1: Understand the regulatory landscape
  • Step 2: Design your Quality & Compliance Process
  • Step 3: Benchmark against industry best practices
  • Step 4: Design standard operating procedures
  • Step 5: Create a Master Quality & Regulatory checklist
  • Step 6: Quality Analytics to derive insights from Quality Data
  • Step 7: Continuous Improvement

In this blog, we focus on how medical device quality leaders must develop a mindset for continuous improvement (CI) of their quality management workflow.

Continuous Improvement is critical for medical device quality management

The quality journey is not a one-time affair. Nor is it stagnant. A more aware customer and an equally aware regulator are constantly upping the demand on the medical device manufacturers to become stringent in applying the rules, to make cheaper, safer and better products. The regulators keep revising the expectations, and the manufacturers have to keep track of the changes to implement them following these seven steps again.
A good EQMS like the one from Compliance Quest allows its customers a bird’s view and a detailed view of the various processes, their progress and their efficiency, enabling:

  1. Compliance,
  2. Flexibility and scalability,
  3. Automation,
  4. Configurable workflows, user interface design and object design,
  5. Mobile-readiness,
  6. Multi-lingual readiness, and
  7. Reports and analytics

The enterprise quality management system from ComplianceQuest leverages the cloud-based platform from SalesForce.com and is built to meet Quality 4.0 requirements through its 12 modules:

  1. Audit
  2. CAPA
  3. Change Management
  4. Complaints handling
  5. Document Management
  6. Equipment Management
  7. Incident Management
  8. Inspection
  9. Non-conformance Management
  10. Risk Management
  11. Supplier Management
  12. Training

Life Sciences is a special area of focus for ComplianceQuest, which has the required experience and expertise to understand the unique needs of the industry and provide bespoke quality management solutions.
In this Whitepaper, we share “A 7-Step Guide to Quality & Compliance for Medical Devices Companies” based on ComplianceQuest’s experience of serving 100+ customer customers in the medical device space.
Read it here: http://www.compliancequest.com/whitepaper/a-7-step-guide-to-quality-compliance-for-medical-devices-companies/

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