Meet Your Regulatory Compliance Requirements

How a Product-Centric Quality Management System (QMS) Improves Control, Traceability, and Compliance

Connecting the Customer Feedback Loop

Connecting Customers

We’ve discussed many aspects of NPD, NPI, and manufacturing. But what happens after your products ship to customers is critical as well. Many medical device companies today have processes and systems in place to identify product issues and customer complaints. However, few have integrated those systems (e.g., CRM) to capture complaints and issues and actually initiate a closed-loop CAPA management process that is tied directly to the product record.

Depending on your product, connecting the customer feedback directly from systems like Salesforce and Zendesk can help you accelerate the analysis and resolution process to save time and money. More importantly, if your product has a greater effect on patient health—then linking your complaint systems to your QMS system can save lives. Smart thermometer company Kinsa is helping to stop the spread of illness, especially during the Covid-19 pandemic, by linking their customer feedback system (Zendesk) to Arena to speed the customer feedback loop.7

Connecting the Customer Feedback Loop

Conclusion

Regulatory Compliance Requirements ConclusionCompanies that rely on disparate, siloed systems face greater obstacles and risks when faced with FDA audits or, worse, with legal liability caused by shipping defective products. The volume and complexity of regulations is not going away and will likely continue to increase over time. The need to create high-quality, low-risk medical devices is crucial to success. Any impediments during the new product introduction process can impact quality, profits, or even human lives.

As you consider the best way to compete in today’s global market with changing regulations, having a single source of quality and product truth is the best hedge against product realization and regulatory compliance pitfalls. So, consider Arena’s cloud-based product-centric QMS as a key advantage to help you not only deliver innovative products that change the world—but also improve the quality of your customers’ lives.

References

  1. https://www.investopedia.com/terms/f/firstmover.asp
  2. Quality Management Survey, LNS Research
  3. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-goodmanufacturing-practice-cgmp-regulations
  4. https://www.rohsguide.com/
  5. https://echa.europa.eu/regulations/reach/understanding-reach
  6. https://www.arenasolutions.com/solution-brief/siliconexpert/, https://www.arenasolutions.com/solution-brief/octopart/

Sections

Delivering Safe and Compliant Medical Devices is Difficult

Why Product-Centric QMS is Best

Strategic Advantages

Strategies for Managing Compliance

How to Reduce Obsolescence Risks

Connecting the Customer Feedback Loop

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