By Sarah Fitzgerald and Stewart Eisenhart, Emergo Group Ensuring adequate processes for corrective and preventative action (CAPA) management is a critical step for medical device manufacturers implementing ISO 13485:2016 or other quality management systems. However, effective CAPA management can prove a perennial challenge even to larger, more mature manufacturers. Get the full story here at […]
MDSAP council updates guidance on conformity assessments and related requirements
By Timothy Herr, Emergo Group Participating regulatory bodies in the Medical Device Single Audit Program (MDSAP) published a new consolidated guidance document, MDSAP AU P0002.005 Audit Approach, which combines the former MDSAP Audit Model and Process Companion Document into a single source of information detailing the process for auditing the quality management systems of medical […]
TriSalus Life Sciences names chief commercial officer
TriSalus today said it appointed Trevor McCaw as chief commercial officer. The chief commercial officer position is new within TriSalus, and McCaw will report directly to CEO Mary Szela. He will be responsible for integrating the company’s therapeutics and innovative drug delivery systems to provide a total solution for patients. Prior to joining the company, […]
Chinese regulators delay medical device UDI implementation
By Stewart Eisenhart, Emergo Group China’s National Medical Products Administration (NMPA) has extended the trial period for its medical device unique device identification (UDI) program in response to the coronavirus pandemic, pushing first-round UDI implementation requirement deadlines to early 2021. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
MDR mutual recognition agreement unresolved after Swiss referendum
By Ronald Boumans, Emergo Group On September 27, 2020, the Swiss held one of their many referendums. Due to the COVID-19 pandemic the referendum in May 2020 had been postponed. This resulted in a total of five issues they were asked their opinion about, so the Swiss had to do a bit of homework before […]
TriSalus names new chief medical officer
TriSalus today said it appointed Steven Katz as chief medical officer. Katz will be responsible for overseeing the company’s clinical development strategy in the treatment of solid tumors. He has served as TriSalus’s chief medical advisor and chairperson of its scientific advisory board since 2018. “We are thrilled to have Steven join TriSalus as a […]
Ampio gains investigational drug nod for COVID-19 inhaler
Ampio recently announced that it received FDA investigational new drug designation to proceed with clinical trials of its Ampion inhaler for patients with COVID-19 respiratory distress. The company is expanding on its recent successful Phase I trial that administered the drug intravenously to COVID-19 patients. The new Phase I trial of inhaled Ampion will total […]
Japan PMD Act revises fast-track reviews for some medical devices, IVDs
By Stewart Eisenhart, Emergo Group Significant revisions to Japanese regulations of medical devices, IVDs and other healthcare products have begun taking effect, with phased implementations (link in Japanese) of new and updated requirements planned through 2022. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
B. Braun wins FDA clearance for MRI-safe infusion pumps
B. Braun this week said it received FDA 510(k) clearance for its SpaceStation MRI to allow infusion pumps to continuously deliver medications to patients in an MRI. SpaceStation MRI is designed to shield Space infusion pumps against 1.5-T and 3.0-T magnetic fields to protect MR scanners while providing interference-free images. Space infusion pumps are able […]
Understanding clinical evidence requirements under European Medical Devices Regulation
By Dietmar Falke, Emergo Group The European Medical Devices Regulation (MDR) demands that “confirmation of conformity with relevant general safety and performance requirements under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk-ratio, shall be based on clinical data providing […]
