Medical Devices & Diagnostics

Navigating the intricate regulatory landscape can be a challenge for medical device innovators seeking a successful path to markets around the world. API empowers life sciences innovators by providing services designed to meet the specific needs of advanced medical and diagnostic technologies.

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What does API do for medical devices & diagnostic technologies?

We provide and connect you to the services and expertise needed for every stage of device development.

At API, we understand the intricate dynamics of advanced medical and diagnostic technologies and collaborate with life sciences companies throughout the entire device development lifecycle. This includes connecting you to facilities and experts on requirements such as MDSAP and ISO 13485:2016 quality management system that will drive your medical device innovations to successful commercialization. Whether your device is a Software as a Medical Device (SaMD), non-in vitro diagnostic (nIVD) or an in-vitro diagnostic (IVD), API has the expertise to support you.

No matter the technology you are looking to develop, we are your strategic partner, connecting you to facilities and experts that will help drive your diagnostics to successful commercialization. From concept to market, our team is here to support your journey.

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Services for Medical Devices & Diagnostics

Within these services, you can expect specialized support for medical devices, particularly in the following areas:

Regulatory Submissions and Applications

Canadian market – Health Canada
  • Device classification
  • Medical Device Licence (MDL) application
  • Private Medical Device License application
  • Medical Device Establishment (MDEL) Registration/Licensing
  • Investigational Testing Authorization (ITA)
  • Small Business Status
  • License renewals and amendments
US market –  FDA
  • Device classification
  • 510(k) notification
  • Premarket approval (PMA)
  • De Novo application
  • Investigational Device Exemption (IDE)
  • 513(g) Submission
  • Small Business Status
  • Registration and Listing
  • Pre-RFD and Pre-Subs

ISO 13485 Third-Party Internal Audits under the Medical Device Single Audit Program (MDSAP)

Grant Writing/Application

Programs for Medical Device Innovators

Here are more resources to get your ideas to market.

In addition to services for the medical device & diagnostics industry, API has a suite of programs and training resources for innovators looking to commercialize their technologies. Whether you’re looking for an incubator, network, or life sciences support and training for your business, check out our programs & training hub.

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Contact us today to unlock the potential of your medical device or diagnostic technology innovation with the support of our life sciences consultation and commercialization services in Canada.