Our transformative compliance solutions were developed specifically to navigate the intricacies of today’s regulatory environment, including compliance strategies from risk-based necessity to value-driven solutions. We provide leadership, strategy development, project management, and a scalable execution team to address any compliance issues that arise.
When faced with deficiencies from an FDA inspection or notified body audit, many manufacturers do not have the bandwidth or experience to respond confidently, let alone make a positive transformation at the same time. Our seasoned team will create a response strategy that builds value and improves corporate compliance.
Our industry expertise allows us to create right-sized solutions, with streamlined CAPA processes that identify compliance issues, investigate, and provide resolutions, so you can avoid 483s and warning letters. Taking appropriate Corrective and Preventive Actions that are focused on the problems and provide direct, sustainable solutions are key to successfully addressing regulatory compliance concerns and building credibility with regulatory agencies.
Unfortunately, recalls are a fact of life for medical device and IVD manufacturers. RQM+ optimizes your recall process to ensure integration with post-market surveillance, applicability to all recall classifications, and a streamlined response plan. RQM+ supports you with a situation analysis, health hazard evaluation, risk-management file review and update, recall strategy, and communication plan to your customers and the agency. From simple issues to emergency responses, we are ready to help you.
Responding to 483s, warning letters, consent decrees, and notified body (NB) non-conformity reports can be daunting. With RQM+, you receive value-added, strategic guidance and solutions that reduce risk and the potential for business interruptions. RQM+’s goal is to help our clients achieve a long-term state of ‘compliance health.'