octobre 5, 2025 - octobre 8, 2025
Network With Our Team at the MedTech Conference
San Diego Convention Center | 111 Harbor Dr, San Diego, CA 92101, United States
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.
Nicole Fowlie
Senior Manager, Commercialization Specialty Services, Innomar Strategies
Nicole Fowlie is Senior Manager of Commercialization Specialty Services at Innomar Strategies, with over 20 years of experience in account management, product launches, and client solutions within specialty pharmaceuticals and logistics. She excels in key account development, managing product launches and delivering healthcare solutions.
Nicole has successfully led proposal development, contract negotiations, and commercial planning for specialty companies entering the Canadian market. She holds a degree in Advanced Business Administration and a background in Canadian History from the University of Toronto. Nicole is dedicated to driving commercialization efforts for small to mid-sized pharmaceutical companies, leveraging her expertise in strategic partnerships to align client needs with integrated service offerings.
Nicole has successfully led proposal development, contract negotiations, and commercial planning for specialty companies entering the Canadian market. She holds a degree in Advanced Business Administration and a background in Canadian History from the University of Toronto. Nicole is dedicated to driving commercialization efforts for small to mid-sized pharmaceutical companies, leveraging her expertise in strategic partnerships to align client needs with integrated service offerings.
Our Expertise
Our team brings a wealth of knowledge and has relationships working with Health Canada and the FDA. Our areas of expertise include regulatory strategic consulting, marketing applications, post-market life cycle, regulatory writing, and quality. We have significant experience across a variety of medical devices and technologies, including
- Implantables
- In Vitro Diagnostics
- Companion Diagnostics
- Software as a Medical Device (SaMD)
- Combination Products
- 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
Connect with us
Fill out the form below to request a time to connect with our experts while attending the MedTech Conference or if you are interested to learn how our expert insights can guide your business decisions.
