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Medical Devices Industry

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Medical Devices Industry

Medical Devices with ISO 13485:2016 Compliance

Medical Devices with ISO 13485:2016 Compliance

Organizations in the Medical Devices and Diagnostics industry face a serious challenge – deliver safe, profitable products on-time, every time. New regulations with tight deadlines such as those for EU’s MDR and IVDR are pushing companies to meet these new requirements to ensure their products continue to remain on the market. But it doesn’t stop there:

Companies can no longer face a compliance “status quo” with all these changes in the market and regulations. More emphasis is being put on risk (as seen in ISO 13485:2016, ISO 9001:2015, etc.,). But in this case, the risk discipline is evolving and being looked at as a tool to create value and achieve higher levels of performance. It’s no longer something to only fear, minimize and avoid. Medical Devices companies will need to change their risk approach from the beginning of the design cycle and throughout the product value chain.

To keep on top of the quality pulse-point, Medical Devices companies are finally moving to a centralized approach bringing “integrated data” from all areas of the company, not just quality, to get a 360-degree view of the truth for both quality and compliance. Through visual dashboards, communities and social collaboration are bringing that data closer to employees to help them perform their job function more efficiently.

Medical Devices with ISO 13485:2016 Compliance

Digital Revolution in Medical Device Manufacturing

ISO 13485:2016 Compliance
ISO 13485:2016 Compliance

Failures in meeting quality compliance hasn’t changed a lot over the past years. We’ve repeatedly seen in 483s, warning letters, etc., that enforcement doesn’t necessarily produce quality. Instead, regulators such as CDRH are encouraging companies to focus more on quality improvements (Case for Quality) creating a culture of quality where everybody is involved in quality, not just the quality department.

Finally, the digital revolution is unleashing innovations that will change the nature of manufacturing. Executives in all industries are using digital advances such as artificial intelligence, mobility, social media, and smart embedded devices, connecting data with every phase of the product lifecycle and transforming the quality value chain for improved operational efficiency and overall patient care.

Finding ways to increase revenue, while maintaining compliance and high levels of product safety is essential to maintaining a competitive edge. ComplianceQuest’s modern cloud-based product, quality and safety solutions help Medical Devices & Diagnostics organizations ensure end-to-end product lifecycle management, safety and enterprise-wide compliance with regulatory requirements, organizational SOPs and industry best practices. Natively built and run on Salesforce, ComplianceQuest modern cloud product, quality and safety management solution offers a powerful, fully integrated platform for internal and supplier audits, change control, complaints, CAPAs, document control, equipment calibration, nonconformances and deviations, inspections, supplier quality, employee training , design controls, PLM and more.

Medical Devices & Diagnostic Equipment

Medical Devices & Diagnostic Equipment

ComplianceQuest’s 21 CFR Part 11 Compliant Solutions Help Medical Devices Companies:

  • Ensure an enterprise-wide state of control and predictable quality to ensure that regulatory and product safety requirements are fully met
  • Take a risk-based approach to manage nonconformances, deviations, CAPA, and Change Management
  • Reduce the cost of compliance, while fully meeting FDA requirements
  • Provide the top-down enforcement of SOPs, Quality System Regulations (QSR), ISO requirements and best practices
  • Improve profitability by reducing variability, eliminating waste, adhering to schedules and commitments, and reducing cycle times
  • Provide a worry-free infrastructure with data and document access anywhere, anytime
Medical Devices & Diagnostic Equipment
Regulations Addressed

Regulations Addressed

  • 21 CFR Part 820
  • EU Directives 2017/745 MDR and 2017/746 IVDR
  • cGMP, cGxP
  • FDA 21 CFR Part 11, EU Annex 11
  • ISO 13485:2016
  • ISO 14971
  • ISO 9001:2015

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