FOR INNOVATION FACTORY CLIENTS ONLY – LIMITED SPACES

Meet 1:1 with the regulatory experts at PTL Solutions to discuss your product, regulatory strategy, and quality requirements. These complimentary Office Hours provide practical, stage-appropriate guidance tailored to your business.

Come prepared with your questions for a personalized consultation. Your PTL Solutions advisor can help you with:

1. Regulatory Strategy & Classification – Determine your device classification and the appropriate FDA and Health Canada regulatory pathway.
2. Software, AI & SaMD – Understand whether your software or AI solution is regulated and what requirements apply.
3. Quality Management Systems – Learn when and how to implement quality systems such as ISO 13485 and FDA QMSR.
4. Clinical & Evidence Planning – Identify the clinical or performance evidence needed to support your product.
5. Commercialization Planning – Align your regulatory strategy with fundraising, pilots, and market entry.

Registration details

Please contact your Innovation Advisor or Greta Black greta.black@innovationfactory.ca to set up an appointment.

Meet the expert

https://www.ptl-solutions.com/

PTL Solutions helps medical device, digital health, and AI-enabled healthcare companies successfully navigate the path from concept to commercialization. Meet one-on-one with their experienced MedTech consultants to receive practical guidance on regulatory strategy, quality management systems, clinical evidence, and market readiness. Whether you’re just getting started or preparing to scale, these complimentary Office Hours will help you make informed decisions and move your innovation forward with confidence.