medvinbio labs private limited

Medvinbio labs is customer centric organization providing end to end solutions for medical device companies future ready to compliant with implementation of new regulations effectively to avoid delay in approvals and keep their products live in this competitive market. Medvin Biosolutions helps in medical device companies in preparing right documentation in line with new changes in regulations which will speed up the overall regulatory approval process. Medvin Biosolutions Services: Biocompatibility tests selection and Compliance Testing as per ISO 10993, USFDA and etc.,; Physical and Chemical Characterization of Medical Devices; Packaging testing and Validation; Sterility, BET and ETO residual analysis; Device master file for Medical Devices and in vitro diagnostic medical devices; Large Animal Preclinical studies; Mechanical Tests for Medical Devices; Third Party Audits; Biological Evaluation Plan; Toxicity and Safety assessment of medical device; Risk Assessment Services; Clinical Evaluation Reports (CER); Risk Management Documentation and ISO 14971; Global Regulatory Compliance; End to End solutions for global Registrations; Detailed Project Reports for Medical Devices; CE, 510(k) & PMA registration support; Support to complying with The Medical Device Rules, 2017 Marketing support global companies to enter into Indian Market Onsite and offsite Trainings.