Registration Details

FOR INNOVATION FACTORY CLIENTS ONLY – LIMITED SPACES

Please email your Innovation Advisor or [email protected] to reserve your spot.

1:1 Mentorship with QualMed

Are you looking for Medical Device Regulatory help? Meet with Gordon Wehner from QualMed to get your medical device regulatory strategy on the right track! Whether you’re an life science startup or seeking to advance your existing medical device journey, Gordon can help provide invaluable insights and address any regulatory-related questions you may have.

Understanding and complying with medical device regulations is crucial to bringing your innovative products to market.  This event is a great opportunity for innovators to:

• Learn how to ensure your products are compliant from the early stages of development
• Navigate the intricacies of compliance and regulatory processes more effectively
• Receive insights into best practices for compliance according to regulations and standards
• Seek clarification on specific regulatory challenges your company may be facing
• Gain insights and updates into the latest requirements and evolving regulations
• Enhance your ability to navigate regulatory hurdles towards development and commercialization
• Identify how to maintain ongoing compliance and address quality concerns after your product is in market

Available Time Slots

10:00am – 10:30am

10:30am – 11:00am

11:00am – 11:30am

11:30am – 12:00pm

About QualMed (Gordon Wehner)

Gordon Wehner, representing QualMed, has been collaborating with life sciences and medical technology companies, as well as healthcare providers, in various areas such as Quality Management, Risk Management, Cyber Security, Type Approvals, Audits, and more in the USA and Finland. With 25 years of experience, his primary focus has been developing quality management systems in start-up or early-stage organizations.

With 25 years of experience, his primary focus has been developing quality management systems in start-up or early-stage organizations.

Gordon possesses extensive knowledge of Canadian Medical Device Regulations, FDA QSR, EU Medical device directive, the upcoming EU MDR, and other international regulatory agencies. He has considerable expertise in validations, sterility and sterilization, implementation of automated systems including ERP and LIMS, and project management. Additionally, Gordon serves as a representative for Canada on the ISO committee for Medical Devices.

https://www.qualmed.ca/