LivaNova, a global medical technology company, announced that Vladimir A. Makatsaria will be the company’s Chief Executive Officer (CEO) and a member of the Board of Directors, effective March 1,…
LivaNova, a global medical technology company, announced that Vladimir A. Makatsaria will be the company’s Chief Executive Officer (CEO) and a member of the Board of Directors, effective March 1,…
…modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026. Until then, manufacturers are required to comply with the existing Quality System regulation. …
…modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026. Until then, manufacturers are required to comply with the existing Quality System regulation. …
As part of its reorganization of the Center for Devices and Radiological Health (CDRH), the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super…
As part of its reorganization of the Center for Devices and Radiological Health (CDRH), the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super…
…requirements and decision-making with downstream payers and purchasers. The project team, which is comprised of experts from across DHP development, regulation, reimbursement and commercial strategy; U.S. payers; purchasers; policymakers; clinicians;…
…requirements and decision-making with downstream payers and purchasers. The project team, which is comprised of experts from across DHP development, regulation, reimbursement and commercial strategy; U.S. payers; purchasers; policymakers; clinicians;…
…Other advantages include: Better compliance adherence Improved vendor-company relationships and support Enhanced product and service quality Unmatched patient experience. Enhanced regulatory compliance. Emergent digital health models, the rising adoption of…
…Other advantages include: Better compliance adherence Improved vendor-company relationships and support Enhanced product and service quality Unmatched patient experience. Enhanced regulatory compliance. Emergent digital health models, the rising adoption of…
…CER consultants come in, as they bring a wealth of experience and skills to the table. Their ability to analyze complex clinical data, identify gaps, and suggest appropriate remediation strategies…
…CER consultants come in, as they bring a wealth of experience and skills to the table. Their ability to analyze complex clinical data, identify gaps, and suggest appropriate remediation strategies…
On January 23, the European Commission put forth a proposal that would extend the deadline for compliance with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. The…
On January 23, the European Commission put forth a proposal that would extend the deadline for compliance with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. The…
The FDA will host the second in a series of medical device sterilization town halls on Friday, January 26, 2024 from 12:00pm-1:00 pm ET. This session, “FDA Activities and Challenges…
The FDA will host the second in a series of medical device sterilization town halls on Friday, January 26, 2024 from 12:00pm-1:00 pm ET. This session, “FDA Activities and Challenges…
