White Paper on The growing role of human factors and usability engineering for medical devices

This white paper is on “The growing role of human factors and usability engineering for medical devices”and is focused on “…applying knowledge of human capabilities and limitations Human Factors and Usability Engineering (HF/UE) contributes to the design of intuitive displays, controls, and other interfaces that substantially reduce the risk of user error.”  It is written by Bob North, Human Centered Strategies.

I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.

White Paper Series 

This is the last planned white paper in this series of white papers.  BSI said of the series that “…we are…producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.”

The other white papers in the series you may be interested in reading, as they are very timely and current, are below:

• Negotiating the innovation and regulatory conundrum
• Engaging stakeholders in the home medical device market
• What you need to know about the FDA’s UDI system final rule
• Effective post-market surveillance; Understanding and conducting vigilance and post-market clinical follow-up
• The proposed EU regulations for medical and in vitro diagnostic devices: An overview of the likely outcomes and consequences for the market
• Generating clinical evaluation reports: A guide to effectively analysing medical device safety and performance

You can sign-up for future white papers or sign-up for their industry sectors newsletter.

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers or preparing for your Notified Body Audit, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

Blog focus BSI’s 2^nd in a series of White Papers for Medical Device & IVD industries, on Generating clinical evaluation reports

White Paper on Generating clinical evaluation reports

This white paper is on “Generating clinical evaluation reports – A guide to effectively analysing medical device safety and performance” and is focused on “…guidance on how to satisfy important regulatory requirements e.g. the concept of equivalence and post-market clinical follow-up (PMCF).”  It is written by Dr Hassan Achakri, PhD, Director, International Clinical Affairs, Zimmer GmbH; Peter Fennema, Director, AMR Advanced Medical Research; and Dr Itoro Udofia, PhD, Orthopaedic & Dental Team Leader, BSI .

I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.

White Paper Series and Future Topics to Come

BSI says of this series that “Throughout the year, we are going to be producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.”

The additional white papers in the series will be on:

• The digital patient
• What medical device manufactures need to know about FDA’s Unique Device Identification Final Rule
• Post-market surveillance
• Usability engineering

You can sign-up for the whole series of white papers too (further down the webpage on BSI’s website). 

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

This posts discusses BSI’s article on the status of the draft ISO 13485:201X standard.  

Recently BSI published an e-newsletter and in it was an excellent article explaining the status of the next draft revision of ISO 13485 and some of the details of the draft standard. The development of this standard project is being managed under the ISO Technical Committee 210, Working Group 1.  The Committee Draft (CD) received over 500 comments and from that the committee published the Draft International Standard (DIS) on 20 Feb 2014.  So, now we are within the required 5 month voting period for comments with the period closing on 20 July 2014.  Note, that some National Committees may ask for feedback up to a couple weeks or more earlier than the 20 July 2014 deadline so get your comments in fast to your National Committee wherever in the world you are.  For most National Committees you or your company have to be members of that committee to submit comments. Note, that since this is at the DIS stage of the process these comments, unless really minor typos, typically will not have an impact on the 3rd revision of the standard but will probably have to wait til the next revision cycle of the standard as at DIS you can’t make any technical changes to the standard. This stage is fairly late in the process and so you aren’t typically allowed to make these types of changes based on how the process is structured in the ISO and IEC standards development process.

When is it anticipated this standard will be released?

The article goes on to say if things run smoothly you may be able to see the actual published standard by late 1st quarter 2015 or early 2nd quarter 2015.  It is expected that there would be some type of transition period established for this standard and this may be impacted by things like the publication of ISO 9001 which this standard relies on, supporting the existing European Medical device Directives and the upcoming Medical Devices Regulations.

The article mentions that you can view a copy of the draft on the BSI National Standards Body website or you can buy a copy as noted in the article. 

If you need additional support in the standards development process for a standard email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151 as he is a Convener for an IEC/ISO, EN and ANSI/AAMI standard for IEC/ISO 80601-2-58 on Lens Removal and Vitrectomy Equipment. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

BSI recently updated the white paper on Proposed EU Regulations for Medical Devices & IVD’s to reflect the latest EU vote in early April, enabling the commission to move forward with the legislation.

Refer to the previous blog post on BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s for additional details about the white paper and the Series of white papers.

You can sign-up for the whole series of white papers too (further down the webpage on BSI’s website). 

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

9 April 2014 – Today marks the beginning of a series of white papers that BSI has just released.  

White Paper on Proposed EU Regulations

This initial white paper is on the “The proposed EU regulations for medical and in vitro diagnostic devices” and is focused on “An overview of the likely outcomes and consequences for the market”.  It is written by some of the best authorities in the business, on this subject, Gert Bos of BSI Head of Regulatory and Clinical Affairs and Erik Vollebregt Partner at Axon Lawyers, that I personally know and trust. I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.  

BSI states that this white paper reviews “the proposals for the new medical devices (MDR) and IVD regulations (IVDR) will provide a new regulatory framework for medical devices in the EU for the coming decades. Although crucial elements of the regulations are still subject to political debate, one thing is clear – the regulations will cause important changes for you. Use this white paper to find out how to prepare for these changes.”

White Paper Series and Future Topics to Come

BSI says of this series that “Throughout the year, we are going to be producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.

The additional white papers in the series will be on:

• Generating clinical evaluation reports: A guide to effectively analyzing medical device safety and performance
• The digital patient
• What medical device manufactures need to know about FDA’s Unique Device Identification Final Rule
• Post-market surveillance
• Usability engineering

You can sign-up for the whole series of white papers too (further down the webpage on BSI’s website). 

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).