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Similing Team

ABOUT US

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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 and Europe. We are a regulatory consultancy and technology company that helps businesses implement international standards, streamline business processes across the organisation, and accelerate global growth. As a full-service Regulatory, Reliability Consulting and sales corporation for medical device, Intro Vitro diagnostic device (IVD), Pharmaceuticals, and product lifecycle, we help companies develop and improve advanced medical devices. MedTechGuys brings you the most exceptional access to a team of consultants who are very experienced with the healthcare industry. We can assist you in getting ISO 13485 certification for a successful MDSAP Audit. We are helping many clients to adhere to Medical Device Regulations. Some of the examples include providing assistance with Medical Device Regulation's compliant documented procedures :

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  • ISO : 13485 procedures

  • Distribution records

  • Complaint Handling

  • Product Recalls

  • Mandatory problem reporting

  • Servicing and Installation

  • Storage & Delivery

 

 

MedTechGuys has well-established partners in the EU, Asia, and USA. Our customers do not only consider us as consultants but as outsourcing partners for medical device regulatory compliance through the manufacturing process. Our experts are devoted to guiding you through the process of developing and launching your new product while ensuring that your product meets with post-market product compliance requirements. In the first place, selling your medical device allows you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Product registration requirements may vary significantly from country to country, which may present challenges for businesses implementing multiple-market strategies. Depending on where you plan to sell your device(s), successful registration can entail significant effort to meet the pre-market technical and clinical submission criteria or to exploit your current listings and approvals to gain faster access to new markets. With MedTechGuys and advisory partners worldwide, we help companies mark their products. The consultants have device registration and regulatory compliance services in established markets.

 

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

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Team

Need more details? Contact us

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

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