Bioteknica

FDA Program Realignment: New Model for Device Approval & Inspection Efficiency The FDA Center for Devices and Radiological Health (CDRH) has submitted a reorganization plan to the agency for review, and the new program model is designed for greater inspection and approval efficiency.  The realignment will impact how medical device companies interact with the agency.  Find out how the agency thinks device manufacturers will benefit from [...]

FDA's Office Of Regulatory Affairs Realigned The FDA’s Office of Regulatory Affairs (ORA), the lead office for agency field activities, has changed its management structure to align its staff by FDA-regulated product instead of geographic region.  At a symposium earlier this year, an FDA official provided an update of key changes at the ORA [...]

New FDA Communications Guidelines For Inspections Medical device companies have new FDA contacts and new guidelines to communicate with the FDA regarding their inspections.  Find your division and contacts and learn more about the guidelines. The Office of Medical Device and Radiological Health Operations (OMDRHO) provides advice to the Office of Regulatory Affairs (ORA) [...]

Modernizing the FDA Workforce A strategic priority identified by the FDA earlier this year is to strengthen the FDA’s scientific workforce by investing in the scientific and clinical expertise of its staff. To keep up with the complexity of modern devices and improve efficiency, the FDA is investing in enhancing the scientific and [...]

Lean Management Systems and the New Normal Miguel E Guerrero, Lean Sensei, Managing Partner, Synergis Corp., a BioTeknica sister company The output of any process, whether business, operational, or economic, should result in outcomes that exhibit high quality, low cost, and timely delivery. Yet, in the medical device and health industry there has been [...]

Medical Device Cyber Risk Management Armin Torres, Principal, Qualified Data Systems, a BioTeknica sister company. Medical Device Cyber Risk Management is the marriage between Safety and Security. It may seem an afterthought that we should be innately capable of living on a safe and secure planet as humans, but what about the connected devices [...]