All photography provided by Jared Chambers
Since 1980, we have led the effort to introduce, inform and inspire companies from around the world. We provide turnkey solutions to Medical Device and In Vitro Diagnostics clients with regard to Scientific, Regulatory and Clinical Affairs.
Our Mission
Iris' Diagnostics consultants assist manufacturers in their regulatory processes. They will clarify the numerous requirements in the European Directives and Regulations for In Vitro Diagnostics and Medical Devices, propose practical solutions to meet them and/or compose your technical documentation and design dossiers. Whether you only need training in the Directives and Regulations or you want to completely outsource your regulatory affairs activities, Iris can provide a suitable solution. While doing this, we take your ambitions outside Europe into account.
With more than 30 years of experience, especially in the In Vitro Diagnostic industry, Qarad's consultants are the perfect support for obtaining the required CE mark, through training, review/composition of technical documentation, assistance in notified body selection and much more. Iris also acts as the European Authorized Representative (EC REP) for In Vitro Diagnostic and Medical Device manufacturers. Our company is the intermediate between the manufacturers and national authorities for a.o. incident management and product notification.
“Iris has provided us with the much needed expertise and direction to get it right, the first time. I can’t begin to tell you how that has brightens this company’s outlook in the European market.”
What We've Achieved
General consulting and training on the In Vitro Diagnostics (IVD) and Medical Devices (MD) Directives and Regulations and their impact on your business and operations.
Practical training sessions on specific parts of the Directives and Regulations, such as risk management and the composition of technical documentation.
Review of your technical documentation to identify any deviations from the regulatory requirements
Composition of technical documentation and design dossiers for notified body assessment.
Organization of performance studies for In Vitro Diagnostic products, according to the applicable standards (Common Technical Specifications, CLSI standards, WHO standards,...)
Management of incidents: incident notification, recall, editing of field safety notices.
Review of your Instructions For Use and product labels. Advise in the design of labeling and optimization for translation.
Audit (gap analysis) of your quality system versus the Directives or Regulations' quality system requirements and ISO13485.
Assistance in notified body selection and in the preparation for a conformity assessment by the notified body.
Advise in the classification of medical devices and borderline products.
All interactions with the national competent authorities.
Support in the case of regulatory actions by authorities versus manufacturers or products in the market.
Literature based scientific validity reports and clinical evaluations reports