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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 ensure their key stakeholders have a master quality and regulatory checklist.

The Master Quality & Regulatory Checklist for Medical Device Quality Management

In early 2020, a Video Laryngoscope Adapter was recalled due to the display of images in reverse. A simple check before sending the product out would have prevented this problem. All it needed was a checklist with an item ‘Check image quality’.
The airline industry has long used checklists to help pilots and aviation professionals deal with unexpected snags. Atul Gawande, a doctor, actually authored a book titled ‘The Checklist Manifesto’ to help doctors and healthcare service providers avoid manual mistakes while treating patients. He suggested hospitals and healthcare providers develop a checklist strategy much like Boeing, the aircraft manufacturer, does. Our suggestion is not different. We strongly recommend to quality leaders to build a checklist strategy to ensure key steps and done and ticked off.
Mistakes are often made by missing, simple-to-do but manual steps. The checklists outline the quality standards and product requirements that everybody down the supply chain is expected to meet, be the suppliers, the workers on the shop floor, the finance team, the procurement team and even the frontline sales team to customer service. Secondly, it helps in ensuring that the product satisfies customer expectations by establishing objective criteria.
Share a detailed quality assurance checklist with your supplier in advance, giving them time to come up to speed or inform you in case of any deviations.

Design a Single Checklist Across all Regulatory Frameworks

As we saw, every region has its own set of regulatory requirements, not meeting which can end up in penalization as well as product recalls. But manually remembering and checking to ensure compliance can be difficult as well as prone to errors. A checklist for regulatory compliance can make all the difference in reaching your product to the intended customer and should be part of your SOP before shipment.
For the checklist to be effective:

  1. It should be clear and direct, making it easy to read and understand,
  2. If you are importing supplies, get it translated into his language for reinforcing clarity, and
  3. The checklist template should be all-encompassing and include:
    1. Packaging requirements including the material being used for packing, labeling, product specifications,
    2. Product requirements such as the specifications, the material and construction, color, markings and labeling, and
    3. On-site tests and checks that your product and packaging need to pass such as barcode scan check, carton drop test, function test or hi-pot test

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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