NBOG Publishes revised best practice guidance documents (Nov 2014)

bio_subbu

Super Moderator
#1
Dear All

The Notified Bodies Oversight Group (NBOG) has published (Nov. 2014) the following revised guidance documents in its series of best practice guidelines on specific aspects related to the activities of Notified Bodies.

To access the guidance documents, refer the below links;

1. NBOG BPG 2014-3 - Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System
2. NBOG BPG 2014-2 - Guidance on the Information Required for Notified Body Medical Device Personnel Involved in Conformity Assessment Activities
3. NBOG BPG 2014-1 - Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general rules

NBOG Forms;

4. NBOG F 2014-1 - Application form to be submitted when applying for designation as a notified body
5. NBOG F 2014-2 - Qualification of personnel (see NBOG BPG 2014-2)

Hope you will find useful…
 

Attachments

Last edited:
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
H Critical Supplier Agreement acc. to NBOG 2010-1 Annex II EU Medical Device Regulations 5
R Technical Files Sampling Rule defined in NBOG 2009-4 EU Medical Device Regulations 2
SteveK NB-MED, NBOG, IMDRF and MEDDEV hierarchy EU Medical Device Regulations 3
bio_subbu NBOG?s Best Practice guidance documents to implement the directive 2007/47/EC EU Medical Device Regulations 0
M Medical Device News Team-NB publishes a press release regarding the designation process in the framework of the IVDR regulation – Regulation (EU) 2017/746 Medical Device and FDA Regulations and Standards News 0
bio_subbu EU Publishes New DIRECTIVE (EU) 2017/2102 AMENDING 2011/65/EU ON ROHS-2 REACH and RoHS Conversations 0
Ajit Basrur FDA publishes "Medical Device Recalls - 2003 - 2012" US Food and Drug Administration (FDA) 1
Ronen E FDA publishes Draft Guidance on Med Dev Pre-Submission Program and Meetings with FDA Other US Medical Device Regulations 0
Ronen E MHRA Publishes Guidance for Notified Bodies on Regulation of IVDs for Self Testing EU Medical Device Regulations 0
bio_subbu EU publishes revised guidance on Medical Devices Vigilance system MEDDEV 2.12-1 Rev7 EU Medical Device Regulations 8
P EU Publishes EN ISO 13485:2012 ISO 13485:2016 - Medical Device Quality Management Systems 14
bio_subbu EU publishes several new & Revised MEDDEV guidance documents (FEB 2012) EU Medical Device Regulations 0
AnaMariaVR2 ISO Publishes Management System Standards for Records Records and Data - Quality, Legal and Other Evidence 2
M UL (Underwriters Laboratories) Publishes IEC 60601 3rd edition FAQs IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
bio_subbu Australian TGA publishes consolidated reference guidelines for medical devices(ARGMD) Other Medical Device Regulations World-Wide 0
S Does anyone know if ISO publishes audit findings/results much like the FDA ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
M Data Protection Act that publishes information within the general factory area Records and Data - Quality, Legal and Other Evidence 3
Sidney Vianna BSI publishes world?s first business relationship specification Other ISO and International Standards and European Regulations 12
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
G New CAPA Work Flow with Revised 8D Approach Process Maps, Process Mapping and Turtle Diagrams 35
M Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201 Medical Device and FDA Regulations and Standards News 2
M Informational Several revised or updates USFDA guidance Medical Device and FDA Regulations and Standards News 0
J Revised MDSAP Audit Model - Health Canada - October 30, 2017 ISO 13485:2016 - Medical Device Quality Management Systems 7
Sidney Vianna SCMH Awareness Webinar Focused on the revised Advanced Product Quality Planning APQP AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Marc Release of New or Revised Procedures Document Control Systems, Procedures, Forms and Templates 5
V Revised ISO std vs ISO13485:2003 - Help Please!!! ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Evalaution of the On Market Device to a Revised Standard Other ISO and International Standards and European Regulations 4
R Re-validating revised Medical Device and Aerospace Product COTS software ISO 13485:2016 - Medical Device Quality Management Systems 2
V Is MHLW Std No.169 - 2004 being Revised in Nov 2014? Other ISO and International Standards and European Regulations 5
J What are the changes in CMDR that was revised in Dec 2013? Canada Medical Device Regulations 2
T CFDA seeks for public comments on newly revised medical device classification rules China Medical Device Regulations 1
M Any new or revised EU or FDA regulatory requirements for IVD diagnostics in 2013? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Singapore - Revised Adverse Event reporting and FSCA Reporting Guidance Other Medical Device Regulations World-Wide 0
M Inventory Parts Have Been Revised Quality Manager and Management Related Issues 7
Ajit Basrur New & Revised Draft Guidances CDER is planning to publish in 2013 US Food and Drug Administration (FDA) 1
L Keeping current on new/revised MEDDEVs EU Medical Device Regulations 8
S Revised MEDDEV 2.12-1 rev 8 Vigilance System - Released EU Medical Device Regulations 3
E Will EN ISO 13485:2012 be revised when ISO 13485 is reviewed?? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Previewing changes to revised Standards US Food and Drug Administration (FDA) 2
P Revised Fiat CSR (Customer Specific Requirements) Customer and Company Specific Requirements 1
S Numbering of Pages in a Revised Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
bio_subbu GHTF issues revised document "Definitions of ?Medical Device? and ?IVD? Other Medical Device Regulations World-Wide 1
M ISO 13485 and FDA QSR Employee Training Requirements when Procedures are Revised Manufacturing and Related Processes 5
J Standards Management - How do we know if a new standard is issued or revised? CE Marking (Conformité Européene) / CB Scheme 9
J What to be reported on "New or Revised Regulatory Requirement" at Management Review? Management Review Meetings and related Processes 8
bio_subbu Hong Kong MDCO issues revised guidelines on listing system for the Medical Devices Other Medical Device and Orthopedic Related Topics 1
J Revised Honda Supplier Quality Manual dated 5/1/2011 Available Customer and Company Specific Requirements 0
S Rolling out a Revised Quality Manual to all the Employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
xcanals_tecno-med.es Revised List of Harmonized Standards for Medical Device Directives (MDD) in the EU EU Medical Device Regulations 48
J Managing New and Revised Electronic Documents (Procedures) - Share Point Document Control Systems, Procedures, Forms and Templates 8

Similar threads

Top Bottom