QARALOGIC
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WE HELP YOU
GET IT RIGHT.
THE FIRST TIME.
Regulatory Affairs and
Quality Assurance
for MedTech Companies
EU-MDR 2017/745 Certification
SERVICES
QARALOGIC clients increase their speed to market, eliminate accumulated system inefficiencies and reduce overall RA/QA cost.
Expand market coverage and access the world.
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For each of our clients we provide a guarantee to achieve agreed upon product and quality management certification goals
WHERE QARALOGIC OPERATES
The key
EU-MDR certification is the key that unlocks the world’s largest jurisdiction for medical devices. We will build a regulatory strategy unique to your technology and guide you through device testing and documentation to ensure maximum clarity during review, shortening your time to market.
We will mediate on your behalf during your device conformity assessment by the Notified Body and make sure that your business meets all requirements under the new regulation.
Quality by process
We believe that a well-designed, well-run Quality Management System is where long-term business success and compliance meet.
We love working with processes and building them from the bottom up. We will ensure that what you have in place covers for all major jurisdictions (US, EU and MDSAP countries) without redundancies, omissions, or superfluous costs.
Going viral
Succeeding in the global market requires effective regulatory strategies, knowledge of best distribution practices, and in-depth understanding of local regulatory landscapes.
We have extensive experience working with Asia-Pacific and Middle Eastern markets and can get your technology there by identifying the most direct paths to clearance by local authorities.
Teamwork makes the dream...
Building the right team with the right combination of talent sets successful companies apart. We have extensive experience hiring and training talent to set your business up for autonomy and growth, whether to position yourself for a great IPO. take you through an M&A, or expand and grow.
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.
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!"
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, Taiwan
"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."
CONTACT US
At QARALOGIC we provide exquisite Regulatory and Quality advisory services for medical device companies. We are certified Regulatory and Quality professionals who are results driven and passionate about bringing the best technologies to patients.
Contact us today and take your MedTech business to the next level!