Looking for regulatory consulting? We'd love to hear from you.

About Us

Hoy & Associates was founded by Connie Hoy after her retirement in 2018. Having worked in industry for 33 years, Connie is well versed in the day to day challenges of developing strategies and obtaining approvals , developing and maintaining quality management systems and encouraging a culture of compliance. Connie decided to start a small consulting firm to help companies of all sizes meet these challenges.

What do we offer? We are really a full-service consulting company for medical devices. We have extensive experience with global strategies and international submission processes. We are well versed in the workings of the FDA and able to help with presubmission meetings and prepare submissions. We offer internal auditing and gap analysis for the quality management system and are able to provide full scope audits including FDA 21 CFR, ISO 13485:2016, Medical Device Single Audit Program (MDSAP), Electronic Product Reporting. We provide an audit report that will withstand the most rigorous scrutiny for regulatory agencies. We also offer on-site training programs for your company.

Hoy & Associates is happy to work with you on any level. There is no project too small or too large.

Our services include:

  • Global Regulatory Strategy
  • Global regulatory submissions
  • US FDA Strategy
  • US FDA submissions
  • Presubmission meetings
  • MDSAP and ISO 13485:2016 Gap Analysis
  • Internal Audits conducted to 21 CFR, MDSAP, ISO 13485:2016, MDD, MDR

Meet The Owner

Photo of Connie Hoy, owner.

Connie Hoy is the founder of Hoy & Associates. She has over 33 years of regulatory experience and has a solid track record that has earned her the respect of key industry players. Her decades of experience sees her time and time again helping companies obtain important global regulatory approvals and pass foreign and domestic audits. Connie has had the opportunity to travel the world and brush shoulders with the best in the industry. She recently stepped down as the Executive Vice President of Regulatory, Quality and Clincial Development at Cynosure, a division of Hologic. She currently enjoys telecommuting as she RVs across the United State with her husband, Howell.

Aubrey Thompson

Photo of Aubrey Thompson.

Aubrey Thompson brings to Hoy Regulatory and Associates a diverse background of technical writing, stakeholder engagement, science communication, and public health research. Aubrey works with clients to:

  • Provide guidance on regulatory strategy and requirements for medical devices.
  • Develop submission applications for 510(k) clearance and Health Canada Medical Device licensing.
  • Research and report on state-of-the-science on medical device technologies and specific indications for use.
  • Provide technical writing expertise for writing and editing medical user manuals.
  • Write and edit medical technical documents.
  • Provide internal auditing for ISO 13485:2016 and MDSAP standards.

Contact Us

We'd love to speak with you! Please submit your information below and someone from the Hoy & Associates team will reach out to you shortly.