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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.

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OUR BEST SELLERS

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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. 

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

 

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

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Europe Medical Device Registration

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

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 Healthcare Warehousing and         Distribution

 

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

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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.

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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

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Healthcare Transportation Services

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

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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.

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Medical Device Single Audit Program (MDSAP)

 

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

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Quality Management System (QMS)

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

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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

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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

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!

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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.

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