• Medical Device Regulations (MDR)• Implementation of QMS as per ISO13485:2016 • Plant Master File (PMF)• Device Master File (DMF)• Approaching to regulatory authority• Documents Preparation & Submission for the Test License & Manufacturing License• Regulatory Software Handling (https://cdscomdonline.gov.in/NewMedDev/Homepage• Product Design & Labeling of the Medical Device• Regulatory Status of the product• Post Market Surveillance (PMS)… Show more • Medical Device Regulations (MDR)• Implementation of QMS as per ISO13485:2016 • Plant Master File (PMF)• Device Master File (DMF)• Approaching to regulatory authority• Documents Preparation & Submission for the Test License & Manufacturing License• Regulatory Software Handling (https://cdscomdonline.gov.in/NewMedDev/Homepage• Product Design & Labeling of the Medical Device• Regulatory Status of the product• Post Market Surveillance (PMS) Data• Corrective Actions & Preventive Actions (CAPA)• Implementation of Product Manufacturing Process• Handling of Post Submission Query• Analytical Performance characteristics• Analytical Sensitivity & Specificity• Claimed Shelf life (Accelerated Stability)• Defining the Quality Specifications of RM/PM/FG • Definition of Assay Cut-off• Stability Studies (In-Use, Shipping, Real)• Product COAs and MSDS• Approved Manufacturing Chemist by the Drug Controller Authority and Involved in the manufacturing of diagnostic products as per GMP guidelines.• Preparation of Batch Manufacturing Record (BMR) Show less

Regulatory, Development, Production and Marketing of the critical & non-critical diagnostic products, Products Dossier Preparation & submission of documents to Central (CDSCO) & State (SLA) Authority. Implementation of the manufacturing process, Preparation of the cost & quality comparison reprot & marketing of the diagnostic products.