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Our life science expertise in medical device, biotechnology, diagnostics, biologics, and
pharmaceuticals are built upon extensive experience globally in quality management system and regulatory design, remediation,
and compliance, product and process validations, design controls, auditing, QSR, ISO, EU MDR, EU IVDR, and driving production
effectiveness, efficiency, and product safety.
Our services span the entire life cycle of life science products and therapy solutions from design and development through verification
and validation efforts and market access and launch. Our solution services are available for not only R&D and regulatory
groups but also address floor level manufacturing challenges.
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Our process excellence practices developed from expertise in implementing
Lean, Six Sigma, Kaizen, conducting process mapping and team facilitation events driving continuous improvement strategies
for operation effectiveness, cost efficiency, waste reduction. Providing program and project management strategic and
tactical support. Leading business transformation initiatives driving very powerful and sustainable change across
manufacturing, transactional, and life sciences industries has been a staple of our success.
For those life science and/or traditional manufacturing companies seeking to innovate and implement a practical process
improvement plan and strategy, we have successfully assisted the medical device, healthcare, pharmaceuticals, site
manufacturing, and telecom service industries (to name a few) with creating a process improvement plan that is customized to each and their
unique needs and executed specific project improvement activities.
Our business transformation and process improvement consultants will analyze your organization operations and processes
to provide advice on how your organization can save money, become more efficient, and exceed customer expectations. Led by
a certified Lean Six Sigma and process improvement expert, we will help you identify the highest-value opportunities, focus
on the most critical challenges and help you create a strategy that will set you apart from competitors.
The Benefits of Implementing Process Improvement Methodologies:
Increased Customer Satisfaction
Implementing improved processes and enhanced quality systems
will result in delivering a better and safety product driving customer satisfaction.
Greater Customer Loyalty
Satisfied customers are customers who will stay
loyal to a brand and comes to expect greatly quality.
Improved Bottom Line
Improved processes and operations drive customer satisfaction and repeat consumers
that translates into an increased revenue stream. Reducing waste in processes, moving the work product through the
system more efficiently, and eliminating bottlenecks all reduce costs which increase the bottom line.
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Our health systems solutions have driven improvements in regional and national
hospitals in driving down patient early readmissions rates, improving corrective action analysis and implementation effectiveness,
increasing joint commission inspection compliance, and improving reimbursement percentage through performance criteria
and score enhancement programs.
Health care is changing at an increasingly rapid pace, and extremely important is making continuous quality improvement as core
competency of any hospital system. Steve Wallace Consulting is committed to ongoing process improvement and process excellence
to increase efficiency system-wide, improve patient care, and help lower health care costs.
Despite their proliferation and importance, quality improvement programs are not a primary observation a patient would
notice in a hospital. Process excellence occurs in the background of day-to-day operations.
Quality improvement and process excellence programs are critical because they drive:
Improved Outcomes for Patients
Improved Efficiency of Staff
Less Waste Due to Process Failures
Drives Increased Monetary Reimbursements
Our consulting hands-on experience and solution expertise cover the following topics:
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• Joint Commission Auditing Preparation and Follow-Up
• Corrective Action Development and Management
• Joint Commission Regulatory Compliance
• Press-Ganey Score Assessment and Enhancement Support
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Our history of designing, developing, and delivering standardized and
customized training classes and enterprise-wide programs in areas such as ISO 13485, 9001, MDSAP, EU MDR, EU IVDR,
Lean, Six Sigma, CMMI, DOE, design controls, risk management, regulatory compliance, design and reliability engineering
techniques has aided our clients in internal skills development and increase the performance and effectiveness of
their internal processes and operational systems.
Our training solutions in addition as stand-alone offerings are often excellent supplements to support our other
life science, process excellence and health systems solutions
Our training programs have been delivered in the United States, Canada, United Kingdom, and Europe in-person and remotely.
Our consulting hands-on experience and solution expertise cover the following topics:
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Compliance Standards Training Programs
Quality System Compliance Training Programs
Compliance Techniques & Best Practices Training Programs
Process Excellence Training Programs
Design and Development Innovation Training Programs
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STEVE WALLACE CONSULTING LLC |
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As an experienced life science and health systems consulting firm with process excellence as a
core competency in all our client solutions, Steve Wallace Consulting guides and assists client across the spectrum achieve and maintain
global compliance standards and improve for business challenges of today. Our experienced team members utilize proven solution
approaches that are customized for the specific environment and needs of each client. Our team members focus on clients needs
with the hands-on solution approach that has proven successful time and again.
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Mt. Juliet, Tennnessee 31722, USA
+001 (615) 210 - 9965
+001 (901) 239 - 6090
For additional questions regarding servies, please e-mail:
info@stevewallaceconsulting.com
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If you are an experienced consultant or FTE interested in learning
about opportunities in supporting current and/or future client projects please e-mail:
swallace@stevewallaceconsulting.com
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