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Meet Hasnaa, Founder of QARALOGIC
With over 12 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.
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
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
TESTIMONIALS DO THE TALKING
Ed Deng, CEO of Health2Sync
"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."
Anthony Jones, Global Digital Solutions Lead at Sanofi
"Hasnaa worked closely with Sanofi in Taiwan to promote adoption of digital health, writing a thorough and well documented white paper and was a speaker and moderator in 2 events Sanofi organised. Hasnaa has deep knowledge of the regulatory landscape in various countries such as Germany and the USA. She can explain complex topics in a simple and effective manner. It has been a pleasure working with Hasnaa and would recommend her warmly!"
Dr. Edward Lin, CEO of HealO Medical
"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!"
Nelson Pang, President RAZ Design
“We selected Hasnaa Fatehi out of a list of several consultants to help with a US FDA project. Hasnaa tackled our project with expertise, dedication and timeliness.
Hasnaa has in-depth knowledge of Quality Management Systems and Regulatory requirements. She has experience working with small and medium-sized, medical device companies and a strong understanding of business pressures.
She worked with our QA/Regulatory Affairs Manager, addressed the issue, documented it for future audits and set up processes to avoid similar situations from occurring again. She also spent a sizeable amount of time educating the team and building our in-house capability. This allowed us to smoothly run our QMS with minimal reliance on her support and successfully pass our annual surveillance audit.
I strongly recommend Hasnaa Fatehi to any medical device company, seeking to place safe and effective devices on the market while balancing compliance and business needs."
Neil Gilchrist, Director at Evonik Canada
An amazingly tenacious and knowledgeable advocate to have on your team. If Hasnaa didn't know the answer you can be rest assured she would go and find the answer.
Always a pleasure to work alongside and a real value add to anybody she works with.
Driven and inspiring, with an ability to raise everybody she works with to the level needed.
Charles Liu, Deputy Business Director, ITRI
Got a chance to know Dr. Hasnaa Fatehi for a while and it was a great experience to have her involved in an international regulatory affairs training together. Not only passion, her expertise has been recognized by me and many global professionals in the RA and QA domain as well.
Prof. Cheryl Dunzeli, BC Cancer Agency
"I strongly recommend Hasnaa Fatehi. She is very professional, knowledgeable, responsive and always willing to answer questions. Hasnaa has been a great help in assisting my team to meet regulatory requirements to bring a novel medical device to investigators and patients and to market. It has been wonderful working with her!"
Dr Samuel Wang, Head of the Regulatory Affairs Department at ITRI
"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."
Senior Director, R&D - Technology Development at Stryker
"I know Hasnaa to be a professional of the highest integrity and very conscientious and knowledgeable in the fields of medical device regulation and quality assurance in domestic, US and international jurisdictions. Clients can be assured of frank and honest guidance from Hasnaa – even when that guidance is difficult to deliver or may be detrimental to her own interests. I have no hesitation in personally recommending her consulting services to any medical technology company seeking RA/QA support and comprehensive and up-to-date advice with respect medical device regulation and quality assurance practices."
OUR CLIENTS
In our experience, the best and most productive partnerships are founded on mutual trust, respect for one another’s expertise and transparency. For that, we rely on goal-oriented and collaborative working relationships to make a difference in patient and user lives.
We have successfully worked with start-ups, Fortune 500 companies and everything in between. Our clients understand that their companies' long-term success lies in intentionally centering patient and user safety in everything they do.
We are scientists (and engineers) who value scientific evidence, learning and creativity.
As certified RA/QA professionals and members of RAPS and TOPRA, we abide by the Code of Ethics and Statement of Values of both organizations and our clients embrace that.
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.
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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