QuRable AB
Medical Devices - Alsike, Uppsala County, Sweden
QuRable AB Employees
QuRable AB Details
QuRable provide consulting services in the MedTech Quality and Regulatory field. Support companies with Medical Device, IVD, and Combination products.Combine leadership, quality assurance, and regulatory affairs, including subject matter expertise in -Product Development-Design Control-Risk Management-Usability/Human Factors Engineering-Biological Evaluation-Software Lifecycle processesQuRable can help you build and develop a compliant -Quality Management Systems per ISO 13485 or cGMP-Technical Documentation for medical devices (MD) or in vitro diagnostic devices (IVD)-Technical Documentation complementary to CTD for drug-devices combination products (DDC). QuRable can support with submissions to and quality audits by Notified Bodies to achieve ISO-certification, product certificates or Notified Body Opinion report.Experiences include a diverse set of products including high risk products and IVD systems such as viscous polymers (incl. animal origin), prefilled syringes, ACT systems, hematology instruments, urine analyzer, anesthetic delivery device, nose spray, vaginal rings with API, wound care device with API, and purified plasma.If you need help sorting out the quality or regulatory parts of your business, QuRable is here to help! #MedicalDevice #MDD #MDR #In-VitroDiagnosticDevice #IVD #IVDD #IVDR #ISO3485 #ISO14971 #IEC62304 #ISO10993 #21CFR820 #21CFR4 #CombinationProduct
