Aug 2017 - Nov 2017        SoftwareCPR.com Newsletter    

 

 

NEW ITEMS on SoftwareCPR.com are listed below

RECENTLY ADDED or UPDATED ITEMS ONLY - BROWSE OR SEARCH THE WEBSITE NEWS, LIBRARY or TOPICS PAGES for detailed information on THESE AND MANY OTHERS. Items denoted with $ are only available to paid subscribers using their login.

 

 

 

SoftwareCPR November 2017 Highlights

 

 

Zig Zilar has said, "There is only one thing worse than training employees and losing them, and that's not training them and keeping them!"  Now is the time to start scheduling in-house training events for 2018.  SoftwareCPR offers 1, 2, or 3 day courses on FDA regulation of software, 62304 and emerging standards, and software risk management.  Contact us at training@softwarecpr.com to see how we can help you keep your teams up to date with the latest standards and FDA expectations and improve the quality of your medical device and HealthIT software.  If you just have a few people to train it’s not too late to sign up for our Jan. 24-26, 2018 public training in Sunnyvale, CA. More info is at http://alturl.com/bbgyc

 

FDA has been prolific in issuing new final guidances including for evaluating software changes to determine if a new 510(k) is needed, interoperability guidance, and De Novo submissions. FDA has also been moving forward aggressively with its Digital Health Precertification Pilot program with companies like Apple and Fitbit participating.

 

SystemsCPR services focused on EMI/EMS and wireless coexistence now has its own web page for more information at http://www.systemscpr.com  as does ValidationCPR services at http://www.validationcpr.com  .

 

 

Regulatory News - Added since last newsletter. Details for each are on website.

11/17/2017

FDA Digital Health Precertification Pilot Webinar

11/10/2017

Free SoftwareCPR Android App with FDA regulations

11/16/2017

FDA Approves Digital Pill

10/31/2017

FDA Final De Novo Submission Guidance

10/25/2017

FDA Breakthrough Devices Program Draft Guidance

FDA Final Deciding if a new 510(k) is needed

FDA When to Submit 510(k) for a Software Change.

10/18/2017

EU Proposed Cybersecurity Regulation

ValidationCPR Blog.

10/17/2017

U.S. Cybersecurity Bill

9/15/2017

FDA PMA Critical to Quality Pilot Program

FDA Recognizes AAMI TIR69 Wireless Coexistence

9/6/2017

FDA FINAL guidance Interoperable Devices

8/30/2017

FDA Abbott Cybersecurity Safety Communication

8/25/2017

IEC 82304 and other FDA newly recognized stds

8/21/2017

FDA Recognizes UL2900-1 for Cybersecurity

8/15/2017

SoftwareCPR August 2017 Newsletter

8/9/2017

FDA Digital Health Precert Pilot FAQ

 


 

 

SoftwareCPR® Educational Material

FDA SW Warning Letters

11/16/2017

$All Recall Excerpts from Jan 2015 - present$

$Warning Letter Excerpts- Jan 2014 - present$

10/31/2017

“FDA MDDS – Still confusing after all this time” blog posting

11/10/2017

Free SoftwareCPR Android App with FDA regulations

11/6/2017

$SCPR Standards Landscape Document Nov 2017$

Available to Standards Navigator and Standards Landscape subscriber using login.

10/18/2017

“Retrospective Validation” blog posting

9/26/2017

“Epics, Stories, and the Epic Story of Agile Medical Device Companies” blog posting

9/23/2017

"HealthIT and Software as a Medical Device" blog posting

8/15/2017

SoftwareCPR August 2017 Newsletter 

 

Brian Pate's Twitter Feed https://twitter.com/BPateCPR

9/16/2017 $Warning Letter Excerpts- Jan 2014 - present$

10/16/2017 Kim Chemicals Private Ltd.

9/7/2017 Wuxi Medical Instrument Factory

 

 

 

 

 

FDA Documents

Standards and Industry Papers

10/31/2017

FDA Final De Novo Submission Guidance

10/25/2017

FDA Breakthrough Devices Program Draft Guidance

FDA Final Deciding if a new 510(k) is needed

FDA When to Submit 510(k) for a Software Change.

10/17/2017

U.S. Cybersecurity Bill

9/15/2017

FDA PMA Critical to Quality Pilot Program

FDA Recognizes AAMI TIR69 Wireless Coexistence

9/6/2017

FDA FINAL guidance Interoperable Devices.

8/30/2017

FDA Abbott Cybersecurity Safety Communication

8/25/2017

IEC 82304 and other FDA newly recognized stds

8/21/2017

FDA Recognizes UL2900-1 for Cybersecurity

8/9/2017

FDA Digital Health Precert Pilot FAQ

9/15/2017

FDA Recognizes AAMI TIR69 Wireless Coexistence

8/25/2017

IEC 82304 and other FDA newly recognized stds

8/21/2017

FDA Recognizes UL2900-1 for Cybersecurity

 

 

 

 


 

 

Conferences and Training

24-26 January 2018 SoftwareCPR Public 62304, SW/HIT stds and regulations training Sunnyvale, CA

This course will focus on 62304 (2015 Amendment) and 80002-1 with some comparison to FDA, and with some overview of new topics related to 82304 for HealthIT software,  62304 2nd edition planned changes, human factors 62366, and regulation of standalone software. More information is at http://alturl.com/bbgyc

11/17/2017 FDA Digital Health Precertification Pilot Webinar

Following the webinar a written transcript, audio recording and slides available  athttp://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm411063.htm

 

24-25 August 2017 *AAMI Effective Application of Agile Practices*

AAMI Effective Application of Agile Practices in the Development of Medical Device Software Aug 24-Aug 25, 2017 Arlington, VA
*Brian Pate of SoftwareCPR is an instructor of this course.* 

 Contact Brian for more information on how to register at brian@SoftwareCPR.com

 

10 October 2017 *FDA Voluntary Medical Device quality Workshop

FDA announced a "Public Workshop - Voluntary Medical Device Manufacturing and Product Quality Program" to be held October 10, 2017. A Webcast is also available and registration is not required for the webcast. For more information see the link provided. 

 

SoftwareCPR® can also provide more tailored training at your facility in these important areas:

_       FDA Design Control and Software Regulation

_       ISO 14971 Risk Management and Software Risk management

_       IEC 62304 Software Development Processes including Agile Methods

_       IEC 62366 Usability and Human Factors Engineering with Risk Focus

_       ISO 13485 and FDA Quality Management Systems

 

Our onsite courses can be provided using a general approach to teach the standards and regulations course or tailored to your products and risk levels.  Each course can be offered in 1, 2, or 3 day formats depending on the number of exercises provided.  All our courses can typically be used to satisfy your training requirements.  We have provided training to regulatory authorities such as the US FDA, Taiwan FDA, and Health Canada. For more information leave a message on our website www.softwarecpr.com or email Brian at brian@softwareCPR.com.

 

FDA Sponsored Workshops and Conferences - see the FDA webpage at

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm

 

Software SW Recalls-New ones since last newsletter. Details for each are on website.

9/16/2017

$All Recall Excerpts from Jan 2015 - present$

11/8/2017

THERMOCOOL SF NAV Catheters Cl II

THERMOCOOL SMARTTOUCH Bi-Directional, Cl II

THERMOCOOL SMARTTOUCH Catheter Cl II

THERMOCOOL SMARTTOUCH SF, Cl II

THERMOCOOL SMARTTOUCH Uni-Directional Cath Cl II

11/1/2017

Ablatherm(R) Integrated Imaging Cl II

Oncentra Brachy 4.5 radiation therapy SW Cl II

Power Processor 1K Stockyard Cl II

10/25/2017

Alaris Pump Module model 8100 Cl II

Philips Healthcare Brilliance 64 System Cl II

Philips Healthcare Brilliance iCT Cl II

Philips Healthcare Brilliance iCT XP Cl II

Philips Healthcare Ingenuity Core X-Ray Cl II

Philips Healthcare Ingenuity Core128 Cl II

Philips Healthcare Ingenuity CT X-RayCl II

Toshiba Medical Kalare Fluoroscopic X-Ray Cl II

9/20/2017

Baxter Amia Automated Peritoneal Dialysis Cl II

Mako Total Hip Application, Cl II

Makoplasty Partial Knee Application, Cl II

Toshiba Medical Radrex, Cl II

9/13/2017

Merge Unity software, Cl II

9/6/2017

Biomerieux VITEK 2 Compact 15, Cl II

Biomerieux VITEK 2 Compact 30, Cl II

Datascope/Maquet Intra-Aortic Balloon Pump Class I

Neusoft Medical NeuViz 64 , Cl II

Neusoft NeuViz 128 Multi-slice CT Scanner , Cl II

8/30/2017

ORA System with VerifEye, Cl II

ORA System with VerifEye+ Cart, Cl II

8/29/2017

Abbott Implantable Cardiac Pacemakers, Class I

8/23/2017

EMBLEM MRI S- Implantable Cardioverter Defib Cl II

EMBLEM S-ICD Implantable Cardioverter Defib Cl II

SQ-RX 1010 Pulse Generator, Cl II

8/9/2017

SoftLab Software Lab information system Cl II

 

More detailed information on the items listed above and many others is available on our website at http://www.softwarecpr.com

 

Website Tips

The NEW items listed above are organized according to their location in the REFERENCE section of http://www.softwarecpr.com. If you have trouble finding an item of interest, send email to office@softwarecpr.com. Note: Items with the “$” symbol on the website including most of items in the Educational Documents category are only accessible to those with valid logins.  If you are not a subscriber, and would like more information on becoming one, click Subscription Page here or from the menu bar. Our annual subscriptions start at $250 and provide access to a large volume of materials include sample procedures, documents, and checklists.

 

Please be sure to check out our “topic” pages. Try these out by clicking Topics.  Paid subscribers should log in and then will have access to all educational documents while others will have only limited access. Remember that additional documents are available by browsing or searching the library.

 

SoftwareCPR® Services and Subscriptions Update:

 

We have expanded our services in the area Cybersecurity to include technical threat assessment and our services related to IEC 62366 and human factors in general now provides end-to-end support including summative usability testing and participant recruiting.

 

In addition to our comprehensive regulatory and compliance services we have specialized software compliance and safety services including hands-on ValidationCPR services and automated testing.

 

We perform FDA Quality System compliance audits and inspection preparation including on-site support during inspections. We also prepare premarket submissions as well as device classification analysis including for grey area Health IT applications.

 

We continue to perform IEC 62304 assessments and assist in developing efficient methods of conformance with these important standards as well as Agile methods compliance.

 

We also provide a service to help you develop Risk analyses and Safety/Assurance Cases including use of your existing risk management documentation. We continue to expand our risk based technical design and code review service.

 

For more information on our subscriptions click standard low cost subscription (as low as $250/year, $500/site, $1000/division or small company). An Add-on for access to our Standards Landscape and quarterly standards updates from Sherman Eagles is available for $200, $400, and $750/year respectively based on type of license We also have a premium subscription service called Software STANDARDS NAVIGATOR led by Sherman Eagles. This provides real time insight, guidance, monthly reports, and access to public draft standards as well as some consulting or training time each year.  Click TOPICS and then click the Standards Navigator topic to get further information.