Our Philosophy

We believe in empowering your organization's team members and systems to be efficient, effective, and compliant.

Our mission is to guide you through the complex landscape of Medical Device Regulations, understand your unique perspectives and seamlessly integrate market launch strategies into decision making. 

By fostering a collaborative partnership, we aim to optimize processes, enhance product quality, and contribute to the advancement of healthcare worldwide. 

Meet the Team

With over a decade of expertise in the medical device sector, each of our seasoned regulatory affairs and quality professionals bring a strong background in biomedical engineering, proven experience in product commercialization, and a keen eye for compliance, enabling strategic decision-making. We've successfully navigated over twenty 510(k) clearances, countless technical file reviews, served as speakers at Regulatory Industry Conferences, and mentored both green and experienced regulatory professionals as senior leaders in the Regulatory and Quality departments of midsize medical device manufacturers.

  • Jessica Piovarcsik

    FOUNDER

    BS Biological Sciences, MS Biomedical Engineering - Cal Poly, San Luis Obispo

    Regulatory Affairs Professional Society (RAPS) RAC Certified

    AAMI CISS - General and EO Sterilization

  • Senior Consultant

    BS Mechanical Engineering

    17 years of experience in Medical Device Engineering, Regulatory, and Quality

    Specialties include: premarket submissions, risk management, change management, global launch strategies, quality management system development, remediation, and implementation, CAPAs.

  • Consultant

    BS Mechanical Engineering

    9 years of experience in Medical Device, Clinical Operations, and Regulatory

    Specialties include: EU MDR, premarket submissions, risk management, change management, global launch strategies, labeling, software development technical files, postmarket reporting, project management, regional configuration management.