Parul ChansoriaRegulatory Pathways to bring a Biological product to the marketWith the aid of biotechnology, we are living in the era where biological products, large complex molecules, are extremely common. These…Jul 24, 2020Jul 24, 2020
Parul ChansoriaClinical trials in South Africa — worldwide accepted dataClinical trials being a resource, cost, and time extensive process, identifying the right location for a clinical trial is paramount…Jul 17, 2020Jul 17, 2020
Parul ChansoriaRUO — A Market Opportunity for IVD companiesGetting an IVD product to the market is a cumbersome task and takes several months to over a year to finally get everything in place…Jul 14, 2020Jul 14, 2020
Parul ChansoriaOfficial Number is now 15 — MDD to MDR + IVDD to IVDR PlanningEveryone knows that the advent of MDR was postponed, and the new regulation shall be in full force from May 26, 2021. As we prepare for…Jul 10, 2020Jul 10, 2020
Parul ChansoriaWho regulates your products?The first step towards bringing your product to the market is understanding which center at the FDA shall regulate your product. The…Jul 7, 2020Jul 7, 2020
Parul ChansoriaAll Pandemics are 100 years old and innovation is older“O lost, and by the wind grieved, ghost, come back again.” as rightly said by Thomas Wolfe; the globe faces a deadly pandemic every 100…Jul 3, 2020Jul 3, 2020
Parul ChansoriaWhat Life Cycle model shall you choose for your SaMD?Software Development Life Cycle (SDLC) is the most important element of a Software as a Medical Device (SaMD) Quality Management System…Jun 30, 2020Jun 30, 2020
Parul ChansoriaHas documentation ever given you a headache?Here are the most common documentation problems that Elexes has helped its Clients with:Jun 23, 2020Jun 23, 2020
Parul ChansoriaSuccessful Certification and MaintenanceThe road to certification w.r.t. ISO 13485 and MDSAP is certainly a long one, but with systematic planning and execution various…Jun 19, 2020Jun 19, 2020
Parul ChansoriaDevelop — Test — CertifyTesting is the most important element of any medical device development. Comprehensive and successful testing certainly helps confirming…Jun 9, 2020Jun 9, 2020
