top of page

Your Most Trusted Health Partner for Life

We specialize in providing the best Medical Devices, Regulatory Advisory and Quality Assurance Services

OUR PRODUCTS

We only deal in certified products that are available in Canada. We offer competitive prices and ensure minimum lead times.

golden-star-ranking-symbol-top-award-vec

OUR BEST SELLERS

363-3633363_burglar-alarm-systems-instal
golden-star-ranking-symbol-top-award-vec

OUR SERVICES

We provide Medical Device Consulting Services and are specialized in regulatory affairs and quality systems. We are specialists of global market submissions especially for Europe, US, and Canada. We are helping medical device manufacturers since 2012.

Our services are specifically designed to help you pass medical device approvals and start selling your device

Health Canada’s expectation as a MDEL holder is that you are following the good practices (GMP) to ensure the quality of the products you distribute.  These practices are demonstrated by following procedures and completing forms associated with these procedures. Our regulatory experts have tirelessly worked to design the Guidelines & standard operating procedures to make your business comply with Medical Device Regulations and to pass compliance assessments stress free. 

    npn2_edited_edited.jpg

    Health Canada Site License & Natural Product Number Registration (NPN)

     

    We use an extremely sophisticated electronic creation system to complete license applications for NHPs

    images.jpg

    Europe Medical Device Registration

    Compliance with CE marking requirements, MDR (Medical Device Regulation 2017/745

    IMG_20200106_094432-scaled-e157963165354

     Healthcare Warehousing and         Distribution

     

    Scalable, customized healthcare logistics, environmentally controlled and cGMP compliant warehouse & distribution centers

    download.jpg

    Canada Medical Device Registration

    MDEL & MDL

    How to Get approval for Canada Medical Device Registration? Health Canada reviews medical devices to assess their safety.

    Register as a small business with Health Canada.

    ISO-9001-13485.jpg

    ISO 13485 & ISO 9001

     

    ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development.

    ISO 9001 – Quality management systems. Medical Device Consulting Services are extended to this standard which can useful for distribution activities

    Transport-services-750x418.jpg

    Healthcare Transportation Services

    From same day delivery to white glove shipping of medical equipment, we provide supply chain solutions to fit your needs

    shutterstock_462488992.jpg

    How to Get The FDA Clearance?

    In order to get FDA clearance for you product, you need to comply with one or more of the following requirements.

    unnamed.jpg

    Medical Device Single Audit Program (MDSAP)

     

    MDSAP program compliance preparation, quality system upgrade, maintenance of the system, mock audits

    quality-management-system.jpg

    Quality Management System (QMS)

    Build a FDA (21 CFR part 820) and ISO 13485-compliant Quality Management (QM) System.

    Experiment

    About Us

    MedTechGuys is a trusted partner, providing end-to-end Regulatory services, across Top 20 global brands.

     

    We are assisting clients worldwide in the areas of regulatory compliance, research and development, quality assurance, distribution and importing.

    MedTechGuys  has also joined hands with some of the biggest medial device manufacturers to supply PPEs at the best price with minimum lead times. We offier:

    • 8+ years of experience

    • Fast and effective solutions

    • Best in class medical devices

    • flexibility

    To learn more visit

    Female Doctor

    OUR TEAM

    Similing Team

    When one considers a group of knowledgeable and experienced professional Engineers, medical device and Pharmaceutical regulatory consultants, quality assurance and reliability experts with dreams of entrepreneurship, merged with a talented sales team dedicated to online medical supplies, what you get is MedTechGuys.

     

    MedTechGuys helps medical device companies with a host of regulatory and compliance issues across the globe mainly in Canada, US & Europe.

    MedTechGuys  also makes online ordering and home delivery of medical supplies accessible to our customers at the best prices in the market.

    OUR PARTNERS

    LATEST ARTICLES

    Aucun post publié dans cette langue actuellement
    Dès que de nouveaux posts seront publiés, vous les verrez ici.

    Need more details? Contact us

          We are here to assist. Contact us by phone or email

    Thanks for your enquiry. We will get back to you shortly!

    • Facebook
    • Twitter
    • LinkedIn
    Facebook_Together-we-can-logo.png
    TheMedtechGuys.PNG
    f2d4f3d6-3779-4614-b264-2ff40abc519a.jpg

    Contact Info

    Got some questions? Need advice? Get in touch with us! 

    Call Us:

    +1 647 449 1105

    Email us:

    info@medtechguys.com

     

    Address:

     

    4011 Brickstone Mews, Mississauga, Ontario, 

    L5B 0J7, Canada

    © 2020 by TransCanada Trade Links Inc.

    shutterstock_559451713.jpg
    shutterstock_559451713.jpg
    shutterstock_559451713.jpg
    shutterstock_559451713.jpg
    bottom of page