Services

Medical Device Regulatory

Kazm.Tech can manage your regulatory journey in the complex field of medical devices. Initially, we can help with classification determination and strategy development.  For example, what claims do you want to make about your device?  We can help you craft your Intended Use statement to avoid potential regulatory pitfalls while maximizing your marketing punch. 

KAZM.Tech will work with you on submission preparation for regulatory agencies including the United States FDA, Health Canada and Notified Bodies for CE Mark. Our track record includes managing many successful US FDA 510(k) Pre-Market Notification submissions including the first multi-platform mobile medical app for diagnostic radiology. 

Seeking to expand your sales into overseas markets? Kazm.Tech has successfully managed the registration and approval processes in China, Japan, Korea, Taiwan, Singapore, Brazil, Costa Rica, Australia, Saudi Arabia, Russia and Hong Kong.

Government Grants

Kazm.Tech has over a decade of experience in securing government grant funding for R&D and go-to-market programs. Successes include contracts for over $9 million from NRC-IRAP, WD WINN, Precarn, Alberta Innovates, TR Tech, Going Global, CanExport and multi-national programs including EUROSTARS and ITEA.  The multi-national programs included assembling a 4-country consortium of 18 organizations - SME's, multinational corporations, universities and research institutes that collectively landed over $25 million in funding. Added experience includes working with the US National Institutes for Health (NIH) and the USAMRMC (US Army Medical Research and Materiel Command).

Kazm.Tech facilitates agency engagement, assessing funding program fit with your priorities and eligibility, preparing submissions and meeting program reporting requirements.

ISO Compliance

Achieving and maintaining ISO Quality Management System compliance for your company is both a major milestone and a significant ongoing commitment.  If you are medical device company, it is often a requirement to be able to market your product.  Kazm.Tech has over 12 years of experience with ISO 9001, ISO 13485, CE Mark and more recently, MDSAP certification. We can help assess your state of process maturity and assist with developing your Quality Manual, SOPs as well as managing the certification process.

Professional Profile

Kyle Peterson - President & Principal Consultant

Kyle Peterson is a Regulatory Affairs professional with recognized expertise in medical devices, software and mobile medical apps including certifications and audits for Quality Management Systems. Kyle also is a management consultant and business strategy advisor focused on the acceleration of innovation and company development through leveraging government funding programs.   In his 12 years in the medical software industry, he has compiled an impressive list of accomplishments including:

  • Delivering 7 FDA 510(k) clearances for Class II medical device software including the first multi-platform (iOS and Android) mobile medical app clearance
  • Attaining and maintaining ISO 13485, MDSAP, ISO 9001 and CE Mark certification for a Calgary-based developer of diagnostic radiology software
  • Securing 11 international approvals including Europe (CE Mark), Health Canada, China CFDA, Japan, Korea, Taiwan, Singapore, Brazil, Costa Rica, Australia, Saudi Arabia, Russia and Hong Kong
  • Securing $9 million in government funding for R&D and go-to-market programs including NRC-IRAP, WD WINN, Precarn, Alberta Innovates, TR Tech, Going Global, CanExport and multi-national programs including EUROSTARS and ITEA.
  • Invited speaker and panelist at numerous conferences including Medica, Xavier Medcon, mHealth Summit, Food & Drug Law Institute, American Association for the Advancement of Science
  • Advisor, Life Sciences Group - Canadian Trade Commissioner Service - Appointed to a group of industry executives representing the medical device, pharma and biotech sectors to advise the Canadian Trade Commissioner Service on their global strategy and programs for the Life Sciences sector.

Kyle’s 12 years in the medical device industry is complemented by 20 years in management positions in the enterprise software industry including marketing, product management, sales, channel distribution, strategic alliances and business development.

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