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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:

  • migrating to ISO 13485:2016
  • reducing audit costs by participating in MDSAP
  • struggling with 510(k) class exemptions
  • preparing for UL 2900 cybersecurity requirements adoption by the FDA
  • push to change to the use of electronic records and signatures in Medical Devices clinical investigations

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”2-16, 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, social collaboration are bringing that data closer to employees to help them perform their job function more efficiently.

Failures in meeting quality compliance hasn’t changed a lot over the past years. We’ve seen repeatedly 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 revenues, while maintaining compliance and high levels of product safety is essential to maintaining a competitive edge. ComplianceQuest’s modern cloud-based EQMS solutions help Medical Devices & Diagnostics organizations ensure product quality, safety and enterprise-wide compliance with regulatory requirements, organizational SOPs and industry best practices. Natively built and run on Salesforce, ComplianceQuest modern cloud EQMS 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 and more.

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 managing 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

Regulations Addressed: