Company: Imaging Devices Manufacturer

Challenge:

Faced with an FDA warning letter, the organization was struggling with over 200,000 backlogged complaints, late MDR reporting, and fragmented processes and systems.

Our Approach:

• Developed and supported the execution of a strategy that resulted in the elimination of the backlogged complaints and the improvement of MDR on-time submission within an eight-month period

• Developed an improved organizational model for the company. New model delivered enhanced capacity and competencies that supported the proper processing of complaints handling and vigilance reporting achieving better operational efficiencies and reduced turnover.

• Aided organization launch new complaints database by supporting the mapping of system requirements, by establishing program management and governance, and by developing the global qualification and training strategy for staff required to use new system.

• and system requirements mapping issues achieving the successful launch of the new complaints database, avoiding $500K in costs

Impact:

✅ FDA warning letter closed

✅ 40% improvement in operational efficiency & 95% reduction in decision-making errors

✅ Successful launch of the new complaints database, avoiding $500K in additional costs

Company: Diagnostic & Imaging Devices Manufacturer

Challenge:

Organization was facing the following challenges: 

• Lengthily lead times to issue customer's initiation letters and to resolve field issues.

• Confusing field action decision making process often leading to incorrect decisions.

• Lack of alignment among stakeholders required to make decisions and execute corrective actions.

Our Approach:

• Identified pain points and developed short and long-term strategy to close overdue field actions and to improve initiation and resolution timelines.

• Standardized KPIs and C&R governance boards to improve visibility and decision making.

• Improved and standardized risk assessments and investigations used to make C&R decisions.

• Developed plan to standardize processes and procedures.

Impact:

✅ Rebuilt regulatory trust

✅ Improved status visibility and governance

✅ Consistent & compliant decision-making

✅ Rapid execution of field actions

✅ Resolution of overdue field actions text goes here

Company: IVD Devices Manufacturer

Challenge:

Organization needed support to address the following:

•  Elimination of redundant registrations and optimization of global QMS.

•  Global site readiness to obtain MDSAP & ISO 13485:2016 certifications.

Our Approach:

• Led Kaizen event with global business leaders and developed strategy to reduce redundant registrations and standardize procedures, and reduce number of notified bodies used by the organization.

• Established a global audit readiness program for MDSAP/ISO 13485.

• and led a global MDSAP/ISO 13485 readiness strategy.

• Established MDSAP/ISO 13485 qualification training globally.

Impact:

✅ Significant cost savings due to reduces registrations and notified bodies

✅ Global MDSAP & ISO 13485:2016 certifications were obtained with no major finding

✅ Standardized, scalable quality system

Company: Cardiovascular Devices Manufacturer

Challenge:

Organization needed support to resolve the following issues:

• Inefficient CAPA review board due to lack of cross-functionality ownership

• Inconsistent CAPA determinations

• Poor Root Cause Determination

Our Approach:

• Standardized CAPA review boards and aligned cross-functional CAPA roles and responsibilities

• Standardized CAPA triggers and CAPA determination processes

• Established CAPA process and root cause analysis qualification program

• Standardized KPIs and analytics

Impact:

✅ CAPA system stabilized globally

✅ Improved CAPA determinations and root cause investigations

✅ Positive feedback from regulators and notified bodies