Guiding clients to effective and efficient compliance and regulatory approvals

COURSE DATES: February 18 – 19, 2019 TRAINING LOCATION: Tampa, Florida, USA COST: 2 Full Days for $2,495.00 January Registration Discount of 10% available through Jan 19, 2018. Meet our newest partner, John Murray, at the course! Download registration form Only a limited number of discounted seats are available – download registration form and email...
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It’s nice to have medical device FDA regulations and guidance accessible without navigating through old websites or lugging printed copies around. Thankfully, SoftwareCPR’s free iOs and Android apps allow you to quickly view medical device regulations and guidance on your smartphone offline! As medical device consultants, we know from experience how important it is to...
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(January 7, 2019)— John F. Murray, Jr, of Mount Airy, MD USA, has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR ®) as a partner. John retired from the US Food and Drug Administration in December 2018 after 32 years of federal service. For 25 years at FDA, John focused on FDA regulated software and...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Standards and regulatory activity overview Medical device software It appears that in response to a question posed by the IEC 62304 working group, the ISO and IEC member countries want ISO 14971 to be required for use of the second...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 12/29/2018 Class I: PRODUCT StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide – Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc. Biopsy Needle Kit (9733068) Note: This device is...
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Clearly one of the great struggles with medical device product design is to understand and finely tune the design input for our devices.  It is difficult but the payoff can be great when done well – pays off with development efficiency, greater certainty with safety risk control, and ultimately in customer satisfaction. In our training...
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It is always good to remind ourselves of exactly what the regulation says – often our corporate procedures can become “bloated” and lead some to believe that some specific activities and/or types of deliverables are required by the regulations.
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Here are some quick links to websites that list the harmonised standards for the different directives.
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One of the most difficult challenges for medical device and HealthIT manufacturers is to properly "level" the design requirements for their medical device systems such that it is clear when it comes to design validation versus design verification.
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Health Canada issued a draft guidance document titled, “Pre-market Requirements for Medical Device Cybersecurity.” Section 1.1 states: “Health Canada considers the inclusion of cybersecurity measures an important consideration in issuing medical device licenses. Therefore, this guidance document provides medical device manufacturers advice on the practices, responses and mitigation measures which can improve the cybersecurity of...
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FDA released a new draft guidance today entitled, “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft Guidance for Industry and Food and Drug Administration Staff“, dated December 17, 2018.  A few things to note related to software: On line 370, question 16, FDA addresses the question of the use of software...
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FDA issued a report entitled “REPORT ON NON-DEVICE SOFTWARE FUNCTIONS: IMPACT TO HEALTH AND BEST PRACTICES – DECEMBER 2018.” This report contains findings on five software functions excluded from the device definition by the 21st Century Cures Act. The FDA found these software functions have more benefits than risks to patient safety and health. The...
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good cyber hygiene
Certainly everyone with any connection to information technology and networked devices is concerned with cybersecurity. However, often we just miss the basics – we do not practice good cyber hygiene. While not intended to be comprehensive or state-of-the-art, here are some security basics (or as some call it, “cyber hygiene”) that one should consider when developing...
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FDA issued a draft guidance for prescription POC (Point-of-care) entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” This draft guidance document provides recommendations to industry about the types of information to include in their premarket submissions for blood glucose monitoring systems used for diabetes management in the health care prescription POC settings. This guidance...
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FDA issued a draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use“‘. This draft guidance document provides recommendations to industry about the studies and criteria to include in their premarket submissions for self-monitoring blood glucose test systems used for diabetes management in the home setting. This guidance (similar to the Prescription POC guidance)...
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Glanced through the latest FDA warning letters today.  From the FDA Medical Device & Radiological Health Operations West/Division 3 I see the inspector pointing out “This design validation also fails to include software validation [emphasis mine] to assure software will perform as intended and will not prevent safe operation by the user.”   Of course this is...
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Company: GE Healthcare, LLC Date of Enforcement Report: 11/29/2018 Class II: PRODUCT Patient Monitoring System used to monitor physiologic parameter data on adult, pediatric and neonatal patients. Recall Number: Z-0519-2019 (Dash 3000), Z-0520-2019 (Dash 4000), Z-0521-2019 (Dash 5000), Z-0522-2019 (Solar 8000i), Z-0523-2019 (Solar 8000M), Z-0524-2019 (Solar 9500) REASON The patient monitors may simultaneously restart as designed if all are connected...
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Company: PerkinElmer Health Sciences Canada, Inc. Date of Enforcement Report: 11/28/2018 Class II: PRODUCT PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872 Recall Number: Z-0513-2019 REASON Under certain conditions...
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Company: Synaptive Medical Inc. Date of Enforcement Report: 11/26/2018 Class II: PRODUCT BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only /...
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Company: Beckman Coulter Life Sciences Date of Enforcement Report 11/20/2018 Class l: PRODUCT The FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers are used to simultaneously analyze multiple characteristics of thousands of individual cells in a relatively short period of time. These devices can be used to diagnose and monitor conditions, like blood cancers,...
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Company: Tosoh Bioscience Inc Date of Enforcement Report: 11/19/2018 Class II: PRODUCT Tosoh AIA-900 immunoassay Analyzer Recall Number: Z-0485-2019 REASON A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later)...
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Company: Voluntis Date of Enforcement Report: 11/16/2018 Class II: PRODUCT Insulia Diabetes Management Companion Recall Number: Z-0478-2019 REASON The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia is...
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The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting...
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Company: Invivo Corporation Date of Enforcement Report: 11/14/2018 Class II: PRODUCT Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 Recall Number: Z-0462-2019 REASON The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the...
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Questionnaire asking the national bodies to choose which approach to risk management should be used in the second edition of IEC 62304: Standards Navigator 62304 Ed2 Questionnaire
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