Willoughby Regulatory Services Ltd. provides regulatory affairs and quality assurance services to the medical device and regulated cannabis industries.

Early regulatory and quality assurance input sets you up for success.

Medical Device Services

Determining the regulatory requirements to bring a medical device to market can be daunting.  Willoughby Regulatory Services Ltd. provides practical, solutions-based guidance and services to achieve your market approval milestones.

We’ll start with a free one-hour consultation to discuss your device and your regulatory and quality assurance needs.      

Following our meeting, Willoughby will provide a written quotation for services.

New product to market?

If you are bringing a new product to market, likely the first step will be to carry out a written regulatory assessment to determine if your product is a medical device, the classification of the device and the requirements to bring the device to market. This regulatory assessment will serve as the basis for a project plan to drive the device to market and ensure regulatory and quality assurance compliance.       

Do you have an established medical device?      

If you already have an established medical device and require regulatory and quality assurance services, Tim is able to provide project-based and continuing services based on your needs.    

Medical Device Regulatory & Quality Assurance Services

  • Tim will help confirm your product is a medical device, determine device classification, the route and requirements to market.

  • Tim will provide assistance with all aspects of design control documentation including planning, design inputs, risk management, verification & validation testing, clinical evaluation and design reviews.

  • Together, we will prepare the required Standard Operating Procedures, Forms and Logs to meet the requirements of ISO 13485, tailored to your internal capabilities.

  • Tim will provide market approval guidance and document preparation. Tim will provide Federal Agency consultations as required.

  • Whatever your needs are, Tim is able provide ongoing compliance activities. Activities include annual licence and registration renewal as well as vigilance activities (recall, incident reporting), post-market surveillance, internal auditing, and device changes.

  • Tim is happy to provide team training and onboarding in regard to Standard Operating Procedures.

Tim has over 25 years of regulatory affairs and quality assurance experience in the medical device industry.

  • “Tim is the real deal, with ample regulatory affairs and quality assurance expertise, but practically minded to balance this with your business imperatives. I recommend Tim in a heartbeat to everyone in medical device development, who needs a quality system and regulatory approvals in any jurisdiction.”

    David Christie, Medical Device Commercialization Executive

  • "I've had the opportunity to collaborate with Willoughby Regulatory Services at several medical device companies. Tim has been instrumental in guiding these companies to achieve their regulatory and quality assurance milestones. It is a pleasure working alongside him; I look forward to continuing to work with Willoughby Regulatory Services in the future."

    Dr. Gabe Kalmar, Biomedical Entrepreneur

  • “I have had the pleasure to work with Tim on a number of projects over the past 10+ years. He is exceptionally knowledgeable and personable. On the projects we collaborated on, he was always able to present the information to the client in a way that was easy for the client to understand.”

    Daryl Wisdahl, Director Quality Assurance & Regulatory Affairs, MedEnvoy Global BV

Cannabis Industry Services

Willoughby Regulatory Services opened its doors to the regulated Canadian cannabis industry with the release of the first published regulations for cannabis. Since 2013, Willoughby has worked with the cannabis industry to create quality systems standard operating procedures, create applications to Health Canada, comply with onsite inspections, and obtain a micro-cultivator and micro-processor licence.  

Working with the regulated cannabis industry since its inception has given Tim valuable insight into the requirements of the Cannabis Regulations and the expectations of Health Canada. 

Cannabis Industry Services

  • Tim will assist you to ensure your facility and security designs meet regulatory requirements.

  • Together, we will create Standard Operating Procedures, forms and logs to meet all Cannabis Regulation requirements. Tim will prepare your facility for Health Canada inspection.

  • Tim will provide project planning and assist you with the necessary documentation to achieve your Cannabis Licence.

  • Whatever your needs are, Tim is able to assist you with ongoing compliance needs, such as annual reports to Health Canada. Other activities could include CTLS portal assistance, facility changes, quality management system changes, and ongoing internal auditing.

  • Tim will provide team training and onboarding to ensure in-house regulatory compliance.

  • "Tim Verspagen has been an instrumental part of my cannabis startup from the start. His approach and attentive service formed monumental help in navigating the regulatory framework of the Cannabis industry. During the first few years this new industry was being formed the regulations went through constant change which required a regulatory compliance consultant outfit that was attentive, flexible and willing to learn. After a long search I found this outfit when I hired Willoughby.”

    Alon Amit, Owner & CEO, Canandia