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What is Unique about us
Our experience and skillset make us the ideal bridge to Europe and Asia
North American
Industry Experience
EU Regulation Expertise
One-stop Shop
Quality System
Based in Canada, with experience bringing North American MedTech innovation to Europe and Asia
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​Mastery of US FDA and Health Canada technical documentation including overlaps with EU requirements
Experience CE Marking Medical Devices and dealing with EU Competent Authorities incl. export/import requirements
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Qualified PRRC, educated in Europe and speaks English, French and German
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In-depth knowledge of MDSAP, 21 CFR 820 and ISO 13485:2016
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Available for in-person audit support and experience with US FDA, Health Canada, ANVISA, NBs (G-MED, BSI, TUV, SGS) audits
Asian Market Knowledge
Experience qualifying OEMs and managing Distributors including product registrations
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Experience working in Asia
(a total of 5 years)
Guaranteed Results
Assurance to achieve agreed upon product and quality management certification goals
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We support from Fortune 500s to research institutes. Past companies we've helped include P&G, Livanova, BC Cancer, Novadaq, Stryker, Sanofi and I-MED Pharma
"Specific to digital health, Hasnaa has very strong understanding of the considerations at stake across multiple parties in the private and public sector, and across multiple geographies. I have enjoyed working with Hasnaa in delivering the relevant and important topics for a successful digital health ecosystem in Taiwan. The work that she produces is high quality and I have enjoyed working with Hasnaa as part of the process."
Ed Deng, CEO of Health2Sync
"Hasnaa is a rigorous thinker and strategist and applies herself to achieving the objectives with the precision of a math formula. She is an excellent investigator and problem solver. I'm pleased with the guidance she has given to my team. She delivers value and deserves your consideration. Highly recommended!"
Dr. Edward Lin, CEO of HealO Medical
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Meet Hasnaa, Founder of QARALOGIC
With over 15 years in regulatory affairs and quality assurance, we have been a trusted guide helping numerous MedTech companies obtain and/or maintain market approvals with nimble proven strategies that assure right the first-time results.
Our clients increase their speed to market, eliminate accumulated system inefficiencies, reduce overall RA/QA cost; and expand market coverage and access to more than a billion people with the CE mark alone.
For each of our clients we demystify the regulations and provide a practical approach guaranteed to achieve agreed upon product and quality management certification goals.
Start today, contact us to accelerate the effectiveness if your RA/QA work and advance medical care in your markets.
"I highly recommend Dr. Hasnaa Fatehi to companies or RA teams who need professional services/comments/strategies in upgrading current RA/QA system to meet more demanding and challenging medical regulations. Have been cooperated with Hasnaa for several projects/events and she always performs better than expectations."
Dr Samuel Wang, Head of the Regulatory Affairs Department at ITRI
So, why us instead of an EU-based consultant?
We get often asked the question, and while we understand the logic behind your concern, there are crucial aspects to account for that only a North-America based EU regulations expert can help you with. This is particularly important to avoid redundancies in testing, technical documentation and overall certification process duplication which ultimately result in significant cost saving.
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To help you think this through, we are happy to discuss key considerations you might want to account for when making your decision on the best advisors to take you through the CE Marking and company's global expansion.​
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