Our services
We offer full management of the manufacturer’s regulatory affairs.
Small or medium sized manufacturers can outsource all their regulatory
activities to Qarad’s experts for effective regulatory affairs
management:
- 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. Qarad has developed an efficient system for
risk assessment and makes document packages available for the creation
of technical documentation and for facilitating conformity
assessment.These sessions will help you to understand all requirements
for CE Marking.
- Review of your technical documentation to identify any deviations from the regulatory requirements.
- Composition of technical documentation and design dossiers for notified body assessment.
- 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.
- Organization of performance studies for In Vitro Diagnostic
products, according to the applicable standards (Common Technical
Specifications, CLSI standards, WHO standards,...)
- All interactions with the national competent authorities.
- Support in the case of regulatory actions by authorities versus manufacturers or products in the market.
- Management of incidents: incident notification, recall, editing of field safety notices.
- Literature based scientific validity reports and clinical evaluations reports