BML Technology understands digital health and the complex stakeholder interactions necessary to get digital health solutions to market. Since our inception we have helped dozens of digital health companies navigate the complex medical device regulatory approval process that medical devices must undergo in order to become compliant and certified for sale and usage in their respective jurisdiction. We perform these services in Canada, the US and Europe.
It is in this role as Health Canada Regulatory Approval experts that we have entered into a collaboration with Adexia, a Montreal based company specialized in supporting companies’ international business development in Canada, and Avisio Qualité, one of our longtime collaborators and leading experts in quality process management, quality systems and ISO 13485:2016 and ISO 9001:2015 implementation.
The Collaboration’s offering is being led by Adexia and referred to as ‘Adexia Santé’. It is a complete solution designed to address the needs of companies in the field of health and medical devices in particular that are based in Europe and seeking to enter the North American market.
We are very excited about this collaboration because of the technology leadership and innovation existing in the medical devices industry in Europe and look forward to assisting in the process of making these available to the benefit of North American consumers.
As part of its efforts the Adexia Santé offering has been presented to member companies of the SNITEM, a France based organization representing more than 500 medical device companies in the medical technology industry, to introduce the Canadian medical device market, best business practices and the medical devices regulatory environment.
We look forward to collaborating with our strategic partners and the many innovative European medtech firms seeking to enter the North American market.
Headquartered in France SNITEM is the privileged interlocutor and referent of the public authorities for medical devices. Anticipating, deciphering, informing, communicating, supporting and defending: these are SNITEM’s missions in order to represent medtech companies on all issues related to medical devices.
About the Adexia Santé Collaboration partners:
A firm specialized in supporting companies’ international business development in Canada and worldwide, since 2006. With offices in Quebec and Ontario as well as partners all around the world, ADEXIA supports its foreign clients expansion and growth in Canada. Their Service Offering includes: Analysis and Strategy, Trade Missions, Business Centre Services, FDI Representation and M&A.
At AVISIO, they believe that quality must be integrated in business management. Quality becomes an accelerator for the commercialisation of innovations. At AVISIO, they are committed to giving the best of themselves by offering a transparent and local service. Along with their dedicated partners, they develop enduring relationships geared towards success.
BML Technology
BML Technology understands digital health. At the intersection of medical technology, clinical research and patient-centric healthcare BML drives the mainstream adoption of digital technology in healthcare. Offering a full range of services to the digital health ecosystem BML manages the complex stakeholder interactions necessary to get digital health solutions to market and gain adoption.
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