Regulatory Compliance
Medical Device Compliance requires evaluation of the Product LifecycleHome »
CHALLANGE
From design to development to testing to release, and post-market surveillance, QRT supports quality, compliance, and regulatory efforts at each phase of the product lifecycle. Our experience allows us to assist with devising proactive strategies that include compliance awareness throughout a project, ensuring your product is ready to be on the market and benefit patients
SOLUTIONS
QRTs’ consulting expertise can provide practical and efficient guidance in the following areas:
Product classification
Regulatory and 510k submissions
Comprehensive validation, covering devices, processes, and software
Unique Device Identification (UDI)
EU Medical Device Regulation (MDR) Compliance
Meeting manufacturing compliance in foreign markets
Risk management
Biocompatibility gap assessment
Handling new product regulatory applications
Development and creation of Clinical Evaluations Reporting (CER)
CE Marking
Corrective Action/Preventive Action (CAPA) procedures
Setting up Quality Management System to meet market requirements, and associated documentation
Testing requirements
Complaints and recall management
Labeling Requirements and UDI Implementation
BENEFIT
Medical device manufacturers are contributing to healthcare achievements around the world, and in order to ensure that safe and dependable instruments are being produced, QRT delivers customized strategies.
Balance your
- Business Strategy
- Patient Safety
- Regulatory Requirements