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Quality, Compliance, & Remediation

We help clients become leaders in product quality, customer satisfaction, and regulatory compliance.

We work with medical-technology manufacturers to capture value from quality improvements across products, processes, and systems. Our sharing of best-practice quality processes helps build organizations that are lean, compliant, and effective—typically resulting in 20 through 50 percent improvement in effectiveness and efficiency.
Our focus on and collaboration with regulators and industry experts on quality, compliance risk assessment, and risk mitigation help ensure patient safety and prevent negative business impacts. We set aspirational goals by benchmarking quality performance, cost, and drivers against competitors.

Examples of our work

Saving $240 million in earnings before interest and taxes

Tracked and managed more than 600 contractors to revise more than 800 procedures, retrain more than 5,000 employees, and remediate tens of thousands of records, which prevented a two-year remediation delay

Developing a quality-management system (QMS)

Designed and executed a QMS in three months—an achievement that included training 25 percent of the business unit with standardized procedures, processes, and measures

Promoting quality-related practices

Increased awareness of quality-related practices among industry regulators and launched ongoing industry–regulator collaboration forums to assess the total cost of quality

Featured capabilities

To ensure a deep understanding of clients’ quality-transformation successes, we invest in developing proprietary tools and methods, including the following:

  • Medical-device–quality benchmarking: An assessment of product quality and cost, resource efficiency, maturity of operations and processes, and culture to identify areas of improvement quickly
  • QMS maturity diagnostic: An assessment of 57 QMS sets of criteria to identify risks and improvement needs
  • “The first 100 days” playbook: A structured approach to quality- and compliance-crisis remediation for quickly restoring control and minimizing negative impacts on business
  • ACQUA: An assessment of employee capabilities to establish and maintain robust quality-compliance operations
  • Semiannual medical-device–quality roundtables: A unique forum that brings together quality leaders and regulators to discuss top industry challenges and potential solutions