Vancouver Team

OUR COMPANY: A MESSAGE FROM THE CEO

My name is Benjamin Arazy and I am the President & CEO of Arazy Group Consultants Inc., an international consultancy spanning several continents, assisting medical device companies with regulatory compliance submissions as they enter new markets. Founded twenty years ago, we now operate in over 100 countries around the world. We have been serving early start-up, medium-sized, and top 100 multinational MedTech companies, and the greatest lesson we have learned through our practice is this:

The future of a medical or diagnostic device manufacturer does not depend only on their ability to innovate; it depends also on their ability to get their products to market.

All medical devices present a common challenge: a medical device is only valuable when it’s available. To be available, a device must be approved and every market requires its own approval. Without pre-market approval, no device can be sold, no revenue can be generated, and no growth can be achieved. In spite of this, the practice of regulatory affairs has not changed for more than 40 years. It remains a fragmented, costly, and inefficient process, managed manually and mostly through local distributors or consulting services.

As growth in the medical device sector continues to shift from the traditional US, EU, and Japanese markets toward emerging markets, and the need to be first to market is becoming more and more important, the regulatory landscape becomes even more complex.  Even in the EU, where requirements should have been harmonized under one directive, some member states still implement their own additional requirements.

While we have been operating for two decades within the constraints of this complexity, we have also seen opportunity. We combined the power of raw data, the efficiency of data management, and the connectivity of a professional social network into a new technology service platform and launched an integrated suite of cloud-based products designed to streamline, simplify, and expedite international regulatory affairs.  Our products and services connect medical device manufacturers, regulatory authorities, and industry experts through one global regulatory management system.

Our disruptive technology is the driving force behind a revolutionary suite of products changing global licensing and registration. Since late 2012, we accelerated growth for our clients and made advanced medical devices available to patients and physicians around the globe faster than ever before. We effectively reduced both the time-to-market and overall license acquisition costs for a medical or IVD device by as much as 50%. And that’s for any device in any of the 100+ markets in which we operate.

What really sets our solution apart is that it delivers KNOWLEDGE ABOVE THE CLOUD™, capabilities that profoundly change the way cloud-based applications deliver results. With our suite of products:

  • The legal department regains control of intellectual property;
  • The VP of sales is released from their dependency on local distributors;
  • The Business Development Manager can gain access to any potential new market in advance without the need for any prior presence or investment;
  • The regulatory affairs department can become a strategic, proactive division of sales and marketing, and finally have control of the registration process in each and every market throughout the complete regulatory lifecycle;
  • COO anxiety is reduced because resources may be allocated and managed more effectively, without worrying about keeping key regulatory employees from moving to other companies;
  • Entrepreneurs of young companies can create significant value just by having product compliance profiles in the system, making products accessible to any market within 3-12 months;
  • And for the CEO, all of this translates into growth, revenue, market share, profit margins, and stakeholder interest.

All of these capabilities are now available for you and are as close as your nearest computer. Whether you are a manufacturer, a regulator, or an expert in the MedTech space, we invite you to join us in driving change and accomplishing our common mission:

ACCELERATE TIME-TO-MARKET BY 50% FOR FASTER AND
EQUAL PUBLIC ACCESS TO ADVANCED MEDTECH PRODUCTS
ON A GLOBAL SCALE.

- Benjamin Arazy
Visit my LinkedIn profile


LEARN ABOUT OUR SERVICES>

BROWSE THE LATEST COMPANY NEWS>

 

latest news
  • Jun 27 2017
    2017 RAPS: DON’T MISS INVALUABLE INSIGHTS ON REGULATORY STRATEGIES FOR MARKET ACCESS

    MedTech regulatory affairs professionals managing the launch of products in new markets and maintaining market approval globally will benefit from the invaluable insights shared during the ‘Regulatory Strategies for Market Access’ session at this year’s R...

    Read More
  • Jun 13 2017
    FDA TO REQUIRE NEW VALIDATION DATA FOR LIST OF REUSABLE MEDICAL DEVICES

    The US Food and Drug Administration (FDA) has unveiled a list of reusable medical devices for which it will require validation data regarding cleaning, disinfection and sterilization as well as validated instructions for use in premarket notification subm...

    Read More
  • Jun 11 2017
    SOUTH AFRICA: NEW REGULATORY AUTHORITY OVERSEES MEDICAL DEVICES

    Medical devices in South Africa are now regulated by the newly established South African Health Products Regulatory Authority (SAHPRA), which has replaced the Medicines Control Council (MCC)....

    Read More
  • Jun 7 2017
    FDA EXTENDS UDI COMPLIANCE DEADLINES FOR LOW-RISK MEDICAL DEVICES

    The US Food and Drug Administration (FDA) has extended the compliance deadlines for the unique device identification (UDI) system requirements for certain class I and unclassified medical devices from September 24, 2018 to September 24, 2020....

    Read More
  • Jun 5 2017
    AUSTRALIA: CONSULTATION ON COMPARABLE OVERSEAS REGULATORS FOR MEDICAL DEVICES OPENS

    Australia’s Therapeutic Goods Administration (TGA) is seeking comments from the MedTech industry and regulators on the use of marketing approval by comparable overseas regulators for medical devices in overseas markets to support the inclusion of them in ...

    Read More

VANCOUVER OFFICE

  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
  •  
  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

BACK TO TOP