Client testimonials

Regulatory and Quality Consulting Services

QA/RA consulting

"Qarad is my first choice for RA/QA support. They were the first consultants I hired when I founded JETA."

Doug Bost
Co-founder and CEO

MDSAP audit

« Thanks to the help and preparation we have received from Qarad, we have been able to successfully pass the MDSAP certification audit without any non-conformities »

Dr. Marijke De Roeve
Quality & Compliance Manager

General consulting

« We appreciate your help in keeping us on track here, as well as everything you've done to help get IDx to this critical juncture. »

CE marking

« On behalf of Wondfo, thank you so much for your great help in CE Mark during the past year. Without your professional and kind services, we would not have our first CE Mark so smoothly. All of us enjoy working with you, ‘Dr. Dirk’ has become very popular among Wondfo and we are looking forward to more co-operations with you. »

ISO Certification

 « Thanks to your pleasant and professional coaching of our team, you had an essential role in our ISO certification. »

Gap analysis

« Our team was very positive about your audit and approach. »

Quality Systems

« The auditor complimented us on the quality of our QMS documentation. Documentation that you helped us put together. Needless to say we are very happy about this, thank you for your help. »

Quality Systems

« AcroMetrix has definitely enjoyed the benefits of your knowledge and expertise with quality and regulatory issues in the EU community for several years. »

Consulting

« It was great having you in for the week. This is exactly the kind of expert quality feedback and training that Pathogenica (and many other companies) need. »

General consulting

« Everybody in Brisbane was very pleased with the work you had done. They had an excellent impression of you, and of what you did. My colleague told me it was the best recommendation he had ever had. You can’t ask for more than that, but I also expected no less. »

E-Labeling / eIFU Services

« Qarad has been very helpful in our recent transition from paper to electronic Instructions For Use. They offer a very professional eIFU service and platform. Changing to eIFU doesn’t only save us cost but it’s also very efficient. And of course good for the environment. Every company should basically be doing this. Apart from being very client focused and flexible, the Qarad team has excellent and up to date regulatory knowledge. »

Peter Kievit
General Manager

“My friend is looking for help in creating eIFUs for her company.  I told her how great it has been to work with you.”

Training

«Thank you very much for your outstanding presentation of the PRRC role.
I feel much more prepared; and, really enjoyed your examples.
Thank you also for providing the slide decks. I will use these as great reference materials as we enter the IVD-R world. »

Dan Kiser
Vice President, Quality, Regulatory

« Very thorough knowledge of content. »

Authorized Representative

« After comparison of many EU representative, I found QARAD is more professional with rich regulatory and technical-scientific skills. There's no doubt QARAD will be the first choice. »

Serena Gao,
Amoy Diagnostics