Better Customer Experience Through Continuous Improvement in Product Quality

Your customers expect a consistent, high quality experience every time. Customer trust, once lost because of repeated quality events, is hard to recover. In the age of social media, poor customer experiences can quickly go viral, which may result in widespread erosion of your brand equity. Even more serious is the possibility of regulatory action, especially if the quality events also compromise customer safety.

We can help you deploy our comprehensive toolkit to help you maintain and continuously improve product quality. Using advanced analytics, we can help proactively monitor both internal and external quality and safety signals to enable timely action before they turn into significant customer issues. Our proven expertise in post-market surveillance can help you build a data-driven, robust process to identify, assess and prioritize product quality improvement opportunities. Finally, we can help you integrate the post-market insights seamlessly with your design control process to help improve future products. We can also significantly accelerate your team’s success through our proven project management expertise.


Effective, Agile & Least Burdensome Regulatory Compliance

Regulatory requirements are changing globally to keep up with rapid technological innovation, complex supply chains and evolving public expectations. Recent adoption of Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) in the European Union, and the Medical Device Single Audit Program are a few examples of these changes.

Whether you are looking for internal audits that uncover vulnerabilities hidden deep inside your Quality System, or supplier audits that enable you to manage risks in your supply chain, our deep expertise in the latest regulatory requirements can provide timely assistance. We can enhance your audit readiness to prepare for agency inspections or third-party audits, and follow up with any remediation activities if needed. Finally, we can help you simplify and streamline your Quality Management System to help you sustain a state of compliance at all times in the least burdensome manner.


Integrated Risk Management Based on Advanced Data Analytics

Risk management in a technology-driven, fast changing world is essential to protect and grow your business. Additionally, regulatory agencies are now adopting a benefit-risk approach to medical product approvals and regulatory actions. Manufacturers are expected to continuously monitor and manage new risks based on post-market experience.

Our expertise in Predictive Analytics can help you monitor and assess medical product safety risks using post-market data from different sources. Our expertise in developing an integrated risk management system will enable you to monitor and assess risks throughout your product’s value chain from suppliers to design, development, production and post-production. Continuous monitoring of risks will allow identification of new risks and de-risking of previously identified risks. Data generated from this monitoring will help you to easily update all product related documents and reports.


Engaged Workforce Through Shared Values & Optimal Organization Design

"Culture eats strategy for breakfast" is a famous quote by Peter Drucker. Even the best of strategies cannot be effectively implemented if the organization’s culture is not favorable. Quality organizations in medical products industry are not immune to this issue, particularly now that the industry is going through a significant transition.

Whether you want to strengthen workforce engagement to align with your current strategy, or develop a new quality policy to lead your organization in a new direction, we can provide the benefit of our experience and deep know-how across different industries. We can help you assess the competency gaps needed for success in the current business environment, and also help you bridge these gaps through effective low-cost training for your entire organization. Finally, we can help you drive cost productivity using cost of quality audits and effective strategies for efficiency improvement throughout your organization.



Ready to ExeedTM the expectations of your customers and stakeholders?