Extensive product exposure and up-to-date technical knowledge ensures our delivery of timely, superior project results.
Our team possesses substantial industry experience, consulting for start-ups to mid-sized companies and to some of the largest global medical device corporations. Partnering with clients to complement their internal resources, we work closely with client design and development teams to support their efforts. We bring more than 50 years of combined clinical and regulatory expertise to every project.


Allison A. Sakara, RN, MSN, PNP/FNP, PHRN

President and Managing Member of Renaissance Worldwide Solutions, LLC, a woman-owned management firm. Allison’s over 30 years of medical regulatory consulting experience serves clients worldwide through RWS’s subsidiary Medical & Regulatory Affairs Specialists, LLC.

One of the nation’s foremost experts in the practice of disaster nursing and disaster healthcare, Allison has dedicated her life to serving those in need in their most desperate hour. In 2005, she was recognized as a Distinguished Member of the Year by the National Disaster Medical System, In addition to direct disaster response roles, she provides expertise on Disaster and Pandemic preparedness for hospital committees, businesses, and educational organizations as the Executive Director of the High Alert Institute, Inc. a 501c3 Not-for-Profit.

Allison’s clinical experience as a nurse and nurse practitioner includes work in pediatrics, hematology, oncology, critical care transport, and disaster response. If there is a tough job in nursing or healthcare that no one else wants, Allison has mastered it. Allison continues to provide medical care and psychological support as both a nurse practitioner and a therapy dog handler. She was also a Technical Advisor for Paramount Television.

Mona Kelley, Healthcare, Workplace, and Home Safety Specialist

Mona Kelley, RN, MSN is a Managing Member of Renaissance Worldwide Solutions, LLC. Beginning as a Senior Research Associate for Medical & Regulatory Affairs Specialists, LLC, she quickly rose to full partnership in the parent company (RWS). Ms. Kelley is an expert in the fields of emergency nursing, trauma care, and disaster response. Combining these scientific strengths with many years of national leadership and mentoring, this graduate of Excelsior and Concordia Universities brings a robust skillset to the RWS team.

Workplace Safety and Health Education are Mona’s passions. She has served on the Emergency Nurses Association (ENA) Foundation Board of Trustees, as President of the Tennessee ENA, and continues to serve as a state and chapter officer. Throughout her tenure, Mona has advocated for the safety of healthcare providers. Today she continues these efforts, working with legislators and healthcare stakeholders to improve safe care environments and practices. Mona also encourages and supports the educational advancement of healthcare workers through the ENA, as well as her collegiate teaching.

Michael Bivins

Electrical and Software Engineer

A graduate of the University of Central Florida, Mike is an Electrical Engineer by education and Software/Systems Engineer by trade with experience in the full life cycle of projects, from the developer aspect to Project Lead in the simulation training fields. Over a 20+ year career, Mike’s roles have included reverse engineering training systems to incorporate upgrades, integration of IT systems to form complete training systems, fielding and training users of simulation systems, information systems security management, systems test engineer, maintenance and training system lead engineer. Mike has developed database infrastructure to streamline data collection techniques and research analysis in the fields of medical research and medical regulatory affairs. He has had a key role in training device and simulator development including transport aircraft maintenance simulators, helicopter training system retrofits, dismounted infantry training systems, and gunnery training systems, as well as alternate energy generation management systems and HVAC controls for energy efficiency improvement. Mike is experienced with OOA/OOD, C, C++, Java, Ada, GUI development (Java Swing fluent), IT Computer Lab development and management, IT systems security, user management, Linux, Windows environments, IA execution, NISPOM compliance, and A+ Certification.

Robert Durham

Information Technology Specialist, Web Developer

With experience in retail, customer service, business management, and various technology specialties, Robert is uniquely equipped to understand real world needs and develop innovative, effective solutions. A self-taught programmer, Robert worked for the Chemistry department at Mercer University and innovated the use of automation at radio stations across Georgia before joining Alco Standard where he combined disparate technologies into cohesive solutions. Always seeking a new challenge, Robert joined an innovative medical organization that was a proving ground for new technologies including electronic billing and electronic medical records. Robert helped pioneer online internet based workplace drug screening, two years before the major laboratories considered the concept.

After a break to recuperate from a life-threatening auto accident, Robert joined High Alert as Technology Section Chief, developing the Social Media Hive concept. Robert now oversees the development of both internal corporate infrastructure and the creation of innovative technology as an contractor for the Renaissance Worldwide Solutions family of companies. Robert’s specialties include: Business Continuity, Disaster Preparedness, Human Continuity, Social Media Marketing, Social Media Optimization, Technology Infrastructure Design and Management.

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