Update to ISO13485 / 14969 - Request for assistance from ISO/TC210 Working Group

R

Roland Cooke

#1
Received from ISO/TC210, I thought this was a good place to highlight it!

ISO/TC210 said:
Ladies and Gentlemen,

As part of the ISO/TC210, Working Group 1 obligation to manage the continuing applicability and relevance of the standards and guidelines it has developed, we are providing the attached questionnaire to quality systems professionals. The purpose of this questionnaire is to determine the need for modification or updating of the ISO 13485:2003 requirements standard and the ISO/TR 14969:2004 guidance document.

The questionnaire is being sent to quality system professionals in government, industry, and the standards communities. This has been circulated to a comprehensive list of recipients (see attached list), however, ISO/TC 210 member bodies and other recipients are welcome to forward this list questionnaire to any government agencies, competent authorities, registrars, notified bodies, accreditation bodies, standards groups, industrial organizations or consultants that are appropriate.

The questionnaire is designed to be thought-provoking, without forcing you to spend more than 10 – 20 minutes to complete.

Thank you in advance for your responses and rest assured they will be given serious consideration.

DEADLINE: 5 June 2007

When completed, please send your responses to Rene Whitehead at either of the following:

e-mail address: [email protected]

or via surface mail to:

AAMI
Attn.: Rene Whitehead
1110 N. Glebe Road
Arlington, VA 22201
USA
 

Attachments

Elsmar Forum Sponsor
R

Roland Cooke

#3
>The questionnaire that was sent previously said “DRAFT” in the header and this has been removed in the attached questionnaire. The content of the questionnaire has not changed.

Best regards,
Hillary Woehrle<
 
Thread starter Similar threads Forum Replies Date
A When will ISO13485 Update be Released? EU Medical Device Regulations 1
S ISO9001:2015 Implementation / update plan template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
M Trigger to update of TLL VDA Standards - Germany's Automotive Standards 0
O IATF 16949 News Ford Motors Customer Specific Requirements Update - Nov 2020 IATF 16949 - Automotive Quality Systems Standard 5
D GMDN code update - Canada - Do you know if there is guidance? Canada Medical Device Regulations 0
Ninja Windows 10 100 % disk use after update Coffee Break and Water Cooler Discussions 33
mike10 QMS Update - Rev. up or start over? Document Control Systems, Procedures, Forms and Templates 3
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
F Software development plan for SW update IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational Update on ISO TC 210 JWG 1 activities Medical Device and FDA Regulations and Standards News 0
M Informational EU – October 2019 update – State-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 2
M Informational US FDA Final and update guidances – Software Medical Device and FDA Regulations and Standards News 2
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M Informational Update from GOV.UK – Regulating medical devices in the event of a no-deal Brexit – UK Responsible Person Medical Device and FDA Regulations and Standards News 0
M Informational Device Shortages Update – The US FDA Announces Two New Innovation Challenges on Device Sterilization Medical Device and FDA Regulations and Standards News 0
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 9
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Digital Health Update: Mid-Year Update on Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Device Shortages Update: Challenges to encourage the development of new approaches to device sterilization Medical Device and FDA Regulations and Standards News 0
M Informational MHRA update – Medical devices: guidance for manufacturers on vigilance - June 2019 Medical Device and FDA Regulations and Standards News 0
M Is it compulsory to update the obsolete GMDN codes in ARTG? Other Medical Device Regulations World-Wide 4
M Informational USFDA – Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
M Informational EU – Update on state-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 1
E Gamma Sterilization Product Update Manufacturing and Related Processes 2
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
B IEC 62304 - Update Checklist IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão Medical Device and FDA Regulations and Standards News 1
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Medical Device and FDA Regulations and Standards News 0
C Do we need to make a new OFI (Opportunity for Improvement) for each document/form we update? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Digital Health Update – New actions and documents Medical Device and FDA Regulations and Standards News 0
M FDA News Digital Health Update: USFDA Report on Non-Device Software Functions Now Available Medical Device and FDA Regulations and Standards News 0
M Medical Device News Letter to the health and care sector: update on preparations for a potential no-deal Brexit Medical Device and FDA Regulations and Standards News 0
Marc Software Update 23 November 2018 Forum News and General Information 1
M Medical Device News Joint Action On Market Surveillance Of Medical Devices (JAMS) Releases Progress Update EU Medical Device Regulations 0
Marc Attachment List Update - 2018-11-16 Forum News and General Information 0
K Medical Device Software Update in Field of AIMD IEC 62304 - Medical Device Software Life Cycle Processes 1
M Medical Device News Health Canada update - Applications for Medical Device Investigational Testing Authorizations Canada Medical Device Regulations 0
M Medical Device News IMDRF update - 26-09-18 - Cybersecurity, Premarket Reviews, Personalized Devices Other Medical Device Regulations World-Wide 0
M Medical Device News TGA update 26-09-18 - Medical Devices Safety Update, Volume 6 September 2018 Other Medical Device Regulations World-Wide 0
M Medical Device News Health Canada Update - 05-09-18 - Pilot Device Advice Canada Medical Device Regulations 0
S How to enforce my colleagues to update SOPs? Document Control Systems, Procedures, Forms and Templates 4
M Medical Device News Health Canada update 28-08-18 - Licensing Requirements for 3D-Printed Devices Canada Medical Device Regulations 0
Marc 2018 Software update - Donations Appreciated Forum News and General Information 21
J Update Technical File for EU Class IIa Medical Software Products EU Medical Device Regulations 3

Similar threads

Top Bottom