Highly qualified industry expert in ISO 13485: 2016, MDSAP, MDR, IVDR, clinical evaluations, PMS, auditing, Technical Files, Risk Management, TRIZ, CMMI, design and manufacturing innvoation initiatives. Strong track record in regulatory compliance, product quality and design.

Steven is a seasoned life science and process excellence solutions consultant with over 25 years of experience in technical and managerial roles in Medical Device and Biologics Industries. Steven has led and supported multiple global remediation engagements for ISO 13485: 2016, MDSAP, EU MDR, and EU IVDR in recent years.

Steven provided Lean Six Sigma, design innovation, design controls , product reliability, program management, quality program management, and merger and acquisition and cultural change services to global life sciences firms and patient quality improvement leadership to hospital systems.

Steven has Bachelor of Science degrees from Virginia Tech in Industrial and Systems engineering, a Masters of Business Administration, and has been Guest Instructor of Biomedical Engineering at University of Memphis.




Highly qualified hospital system and healthcare professional in clinical management, Joint Commission auditing preparation and corrective action management, risk management, and insurance regulations. Highly respected performance record in hospital system regulatory compliance and patient care quality.

Jenifer is a seasoned healthcare professional with over 25 years of experience in both clinical and managerial roles in various hospital systems. She has developed and implemented innovative patient care programs, policies, and procedures, to include cultural diversity, and incorporate best practices for patient-centric care.

Jenifer has worked with The Joint Commission and Tennessee Department of Health and is very knowledgeable about the regulations and requirements of both. She has implemented strategies to increase Press-Ganey scores to the 90th percentile.

Jenifer has both a Bachelor of Science in Nursing and a MBA from University of Memphis. She has been a Certified Rehabilitation Registered Nurse since 2012.

SOLUTION CONSULTANTS

We have a team of solution consultants supporting client specific skills needs such as auditing, quaity system remediaton, and healtcare patient satisfaction assessment as needed.