Device and Diagnostic Regulatory and Quality Solutions

Guidance and insight at each stage of the product lifecycle

We offer Regulatory and Quality Assurance guidance, and insight, for the medical device industry, at each stage of the product lifecycle. The senior consultants at TPIreg have extensive experience and relationships working with Health Canada and the FDA. Areas of expertise include; regulatory strategic consulting, marketing applications, publishing, post-marketing life cycle, regulatory writing, and quality.

We can guide you through

Innomar has extensive experience with medical devices, in vitro diagnostics, companion diagnostics and combination products. Our areas of focus include orthopedics, gastroenterology, general surgery, dermatology, gynecology, imaging, respiratory, ENT, ophthalmology, urology, wound care, dentistry, infection control, and oncology.

Regulatory Consulting

  • Strategic Regulatory and Compliance Consulting Advice
  • Reimbursement and Market Access
  • Agency Meetings (Pre-ITA, Pre-Submission Appeal and Q meetings)
  • Review of Safety and Efficacy Evidence in Support of Device Registrations
  • Companion/Combination Product Requirements

Submissions

  • Product Classification/Request for Designation
  • Applications for Test Kit Numbers (Controlled Substances)
  • Clinical Trial Application Guidance and Submissions (ITA and IDE)
  • Licence applications (Class II, III and IV) for Medical Devices and IVDs)
  • Medical Device Marketing Applications (510(k), PMA)

Quality & Establishment License Services

  • Quality Management Systems to meet ISO 13485:2016 (MDSAP), FDA GMP 21 CFR 820; internal and supplier audits
  • Medical Device Establishment Licence applications for importers and distributors (MDEL)

Our Device and Diagnostic Regulatory Leader 

Shirley Furesz, Ph.D., RAC, Director, Regulatory Affairs Medical Devices

Shirley Furesz is Director, Regulatory Affairs Medical Devices at TPIreg™, a Division of 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 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 TPIreg™, 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.

Looking for Regulatory and Quality Assurance guidance? We have a strategic approach at each stage of the product lifecycle.

Medical devices used in surgery