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Most of us are familiar with the fast-paced world of MedTech and the mounting pressures to maintain product quality, safety, and compliance companies face. With the FDA increasing the number of Class I recalls and the EU MDR/IVDR placing greater responsibilities on the Person Responsible for Regulatory Compliance (PRRC), the consequences of non-compliance can be severe, impacting financial performance, company reputation, regulatory standing, and user/patient safety.
Fostering a Culture of Quality
To succeed in this environment, MedTech companies must prioritize a Culture of Quality. This means making quality and safety the guiding principles behind every decision and action. While cost-saving measures are important, compromising on quality and compliance can lead to significant long-term repercussions. By instilling a Culture of Quality, companies can make routine what other companies spend months or years correcting. A Culture of Quality enables open communications and alignment on issues without fear of repercussions. It also reinforces continuous improvement and removes the roadblocks for those course corrections that are constant in our industry.
A company who truly embraces a Culture of Quality should have fewer regulatory findings, fewer product complaints/product issues, less scrap, and fewer field corrections. That same company should expect to see positive employee morale, a reduction in stressful work environment, increased customer loyalty which translates into increased revenue and market presence.
Implementing Continuous Monitoring
Continuous monitoring is essential for ensuring that products and processes are meeting the intended outcomes. This involves:
- Implementing robust systems to track product quality trends
- Identifying new and potential risks
- Taking corrective actions when necessary
Management review plays a vital role in this process, allowing Quality Management and senior leadership to assess quality trends and make informed decisions based on data-driven insights. When product issues arise, focused investigations, along with conducting a thorough Health Hazard Evaluation, are crucial to assess the potential risks to users and patients. Every medical device company should have healthy complaint handing, post-market surveillance, CAPA, and Risk Management processes and systems in place to quickly identify issue trends, assess risks, and take action when necessary. If these processes and systems aren’t in place or are not healthy, a company can miss indicators that new issues are manifesting or there are new risks that could affect users and patients.
If you feel like these systems may be lacking, an audit or gap assessment may be needed to identify areas of improvement for piece of mind. Starting with a process audit or system gap assessment may bring to light deficiencies that weren’t obvious on a day-to-day basis. Once the gaps are identified, remediation may be necessary to close those gaps and test updated systems for robustness. Remember, you don’t know what you don’t know. By conducting the audit or gap assessment, you will have data to show your processes and systems are either working or are in need of improvement.
Four Steps to Remediation
- Conduct a comprehensive audit of the Quality Management System (QMS) and a gap assessment of the primary product's technical files. This will provide visibility into the majority of issues that can lead to field action crises. For more information on the importance of audits, read our 8 Strategic Advantages of Outsourcing Audits technical brief.
- Take swift action to develop a remediation plan, then remediate identified gaps, either through internal resources or by engaging external subject matter experts for an unbiased assessment. Remember to consider how one process (or system) links to another. Changes made in one process may affect another.
- Develop a strategy to maintain ongoing compliance, keeping products and processes current and continuously updated. This allows companies to maintain a state of inspection readiness at all times.
- Implement a robust closed-loop risk management system to identify and address issues as they occur, as well as routinely review your risk management files against post-market data. This involves gathering data from multiple sources and regularly reviewing product risk assessments, complaint coding for new risks, and ensuring reportability guidance is current.
Partnering with RQM+ for Success
At RQM+, we understand the challenges that MedTech companies face first hand. Our team of experts offers specialized solutions across the full product lifecycle, from concept to commercialization to post-market. By partnering with RQM+, you can accelerate your compliance and market success, while minimizing the risk of costly regulatory action.
The road to remediation may seem daunting, but by fostering a Culture of Quality, implementing continuous monitoring, and taking proactive steps to address gaps, MedTech companies can ensure the quality, safety, and compliance of their products. Partnering with a trusted service provider like RQM+ can provide the expertise and support needed to succeed in today's challenging regulatory environment.
Watch the On-Demand Panel Discussion
For further insights on how to proactively prevent crises and protect your customers, patients, and reputation, watch our on-demand panel discussion Get Ahead of the Crisis: How Your Quality System Can Prevent Negative Impacts on Customers, Patients, and Reputation. In this session, our experts cover the best strategies for preparing for crisis management, including the importance of change control, post-market surveillance data, clear decision points, internal audits, and fostering a culture of quality.
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