Medical device testing guide

From Medical Design & Outsourcing

• Supply chain tool IDs COVID-19 supply shortages
  The American Society for Microbiology (ASM) has developed an online platform to identify COVID-19 and non-COVID testing supply shortages. In partnership with the Associaton for Supply Chain Management (ASCM), ASM developed the platform to identify and monitor the testing supplies to be made aware of shortages in real-time, according to a news release. Get the… […]
• Saraca Solutions seeks to slash clinical evaluation report times
  Saraca Solutions announced today that it has developed a tracking tool to reduce the time it takes to create an update for a clinical evaluation report (CER). A CER documents conclusions for a medical device’s clinical evaluation. It consists of analyzed clinical data collected from either investigation of a company’s device or studies of substantially… […]
• These small companies are making big COVID-19 contributions
  Major companies continue grabbing the headlines around the COVID-19 pandemic, but smaller companies have contributed their share toward helping patients, boosting research and keeping frontline workers safe. This week, Minnesota’s Medical Alley Association issued a report on its members’ pandemic responses, including companies large and small, from telehealth providers to a tube-feeding company. We wanted… […]
• Schurter adds switch for harsh environments
  Schurter recently debuted a piezoelectric switch, PSE, which is installation-ready with its pre-assembled 15-meter-long cable. The potted polyurethane cable offers installation flexibility with the highest IP67 protection according to IEC 60529 and IP69K according to DIN 40050-9, according to the company. Designed to be waterproof from its surface to its electrical connections the switch’s housing… […]
• 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… […]
• Abiomed touts latest Impella trial results
  Abiomed (NSDQ:ABMD) today announced interim results of a study that found high-risk patients had better outcomes after implantation with its Impella CP heart pump. Data from the PROTECT III FDA post-approval study of Impella 2.5 and Impella CP in high-risk percutaneous coronary intervention (PCI) patients showed reduced rates of MACCE — a composite of death, stroke,… […]
• Zynex cites growth in shifting manufacturing from HQ
  Zynex (NSDQ:ZYXI) recently announced the lease of a new 50,488 sq2 warehouse for manufacturing and inventory. The Englewood, Colo.-based developer of non-invasive medical devices for pain management, stroke rehabilitation, cardiac monitoring and neurological diagnostics said the new building will expand inventory capacity by three to five times compared to its current facility. The 65-month lease will… […]
• Aferetica, CytoSorbents gain EU nod for organ perfusion system
  CytoSorbents (NSDQ:CTSO) and Aferetica today announced the European Union approval of Aferetica’s PerLife integrated ex-vivo system to perfuse, cleanse, recondition and preserve harvested kidneys and livers — including those that are usually discarded. Italian startup Aferetica designed its PerLife system to improve organ function and viability while reducing the risk of primary graft failure and… […]
• Spartech names new CEO
  Spartech announced today that John Inks has been promoted to CEO. Inks previously served as COO for the St. Louis-based manufacturer of engineered thermoplastics and custom packaging. Inks has served in a variety of leadership roles at Spartech over the past 13 years, including finance, operations and commercial roles. He was promoted to VP of… […]
• Choosing the Right Medical Power Supply
  Because modern medical equipment heavily leverages advances in the computing and electronics fields, it is increasingly critical to select the right power supply to meet functional and regulatory requirements. This paper discusses the unique design requirements for medical power supplies, and how to select the right medical power supply for your application and product. Download… […]
• 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… […]