Day 1
Ask the Speakers
Wrap up the first day of the conference with an engaging Q&A session featuring our keynote and panel speakers. This interactive session offers attendees the opportunity to ask questions, gain deeper insights, and explore key topics discussed throughout the day. Don't miss this chance to connect directly with Health Canada and industry leaders!
Session sponsored by Cencora (Innomar Strategies)
Shirley Furesz, Ph.D., RAC
Director Regulatory Affairs, Medical Devices
Shirley Furesz is Director Regulatory Affairs, Medical Devices at Innomar Strategies Inc. She has been working as a regulatory affairs consultant since 2006 and has extensive experience with medical devices, in vitro diagnostics, companion diagnostics and combination products including those used in orthopedics, gastroenterology, general surgery, dermatology, gynecology, imaging, respiratory, ENT, ophthalmology, urology, wound care, dentistry, infection control, and oncology.
Shirley received her Ph.D. in the area of vaccine development from the Department of Veterinary Microbiology and Immunology at the University of Guelph. She provides regulatory strategy and manages a wide range of device submissions for Health Canada and other regulatory agencies. Shirley achieved her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society in 2009.
Prior to joining Innomar Strategies, she was a key member of the medical devices consulting team at Icon plc (previously Mapi Life Sciences, OptumInsight and CanReg Inc.) and has held various research positions at Syn-X Pharma and NoAb BioDiscoveries Inc. in the areas of Point of Care Diagnostic Kit development, Proteomics, Cell Biology, and ADME-Tox testing.
Shirley received her Ph.D. in the area of vaccine development from the Department of Veterinary Microbiology and Immunology at the University of Guelph. She provides regulatory strategy and manages a wide range of device submissions for Health Canada and other regulatory agencies. Shirley achieved her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society in 2009.
Prior to joining Innomar Strategies, she was a key member of the medical devices consulting team at Icon plc (previously Mapi Life Sciences, OptumInsight and CanReg Inc.) and has held various research positions at Syn-X Pharma and NoAb BioDiscoveries Inc. in the areas of Point of Care Diagnostic Kit development, Proteomics, Cell Biology, and ADME-Tox testing.
Meet the team
As a leading provider of regulatory and quality assurance guidance, the Innomar Strategies Regulatory Team is committed to supporting your medical device needs at every stage of the product lifecycle. With extensive experience and established relationships with Health Canada and the FDA, our senior consultants offer a deep well of knowledge and expertise.
Cathie Rutt
Director, Quality Assurance
Janice Wright
Senior Manager, Regulatory Affairs Medical Devices
Katia Simao
Manager Regulatory Affairs, Medical Devices
Our Expertise
We specialize in a wide array of regulatory and quality services including, but not limited to:
- Regulatory Strategic Consulting
- Marketing Applications
- Post-Market Lifecycle Management
- Regulatory Writing
- Quality Assurance
Our team has significant experience across a variety of medical devices and technologies, including:
- In Vitro Diagnostics
- Companion Diagnostics
- Artificial Intelligence/Machine Learning
- Software as a Medical Device (SaMD)
- Combination Products
- 3D Printed Medical Devices
- Wearables and Medical Applications
Focus Areas
We provide tailored regulatory services across multiple therapeutic areas, including:
- Orthopedics
- Gastroenterology
- General Surgery
- Cardiology
- Dentistry
- Dermatology
- ENT
- Gynecology
- Imaging
- Infection Control
- Respiratory
- Urology
- Wound Care
Comprehensive Regulatory Services
Our team is equipped to guide you through the complexities of medical device regulation in Canada and the USA, offering services such as:
- Regulatory Strategy and Compliance Consulting
- Personalized Regulatory Intelligence for Canada
- Comprehensive Product Lifecycle Support
- Facilitation of Agency Meetings (Informational, Pre-ITA/IDE, Pre-Submission, and Appeal Meetings)
- Canadian Applications for Test Kit Numbers (Controlled Substances)
- Gap Assessments for Safety and Efficacy Evidence
- Guidance on Companion and Combination Product Requirements
- Market Access and Reimbursement Consulting
- Medical Device Clinical Trial (ITA and IDE) Guidance and Submissions
- Post-Market Surveillance and Medical Information Call Centre Services
- Product Classification and Registration Applications (Class II, III, IV MDL, 510(k)s, De Novo, and PMAs)
- Quality System Implementation to Meet ISO 13485 (MDSAP) Standards
- Support for Canadian Medical Device Establishment Licences (MDEL) for Class I Manufacturers, Importers, and Distributors
- US Registration and Listing
Let's Connect at Canada's Regulatory & Quality Medtech Conference 2025
Our team will be on location to meet with you. Schedule time to connect with our experts while attending the Regulatory & Quality Medtech Conference to discover how we can help you ensure patients can access devices needed to create healthier futures.