QuRable AB

QuRable provide consulting services in the MedTech Quality and Regulatory field. Support companies with Combination products, Medical Devices, and In-vitro Diagnostic devices. 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 processes QuRable 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 regulatory submissions and quality audits, ISO-certifications, product CE-certificates or Notified Body Opinion reports, to achieve EU or US market access. Experiences include a diverse set of products including injectable devices, drug-delivery devices, injectable drugs, nasal sprays, wound patches, vaginal ring with API, dermal filler, hematology analyzer system, antimicrobial susceptibility test system, urine analyzer system, biomarker detection system. If you need help sorting out the quality or regulatory parts of your business, QuRable is here to help! Email: [email protected] #CombinationProduct #21CFR820 #21CFR4 #MDR #Art117 #NotifiedBodyOpinion #MAA #NDA #MedicalDevice #MDD #In-VitroDiagnosticDevice #IVD #IVDD #IVDR #CE #510k #PMA #ISO13485 #ISO14971 #IEC 62366-1 #ISO10993 #IEC62304 #IEC81001-5-1 #ISO20417 #ISO11608

• Employees1
• Founded2021