Keeping current on new/revised MEDDEVs

lboll

Involved In Discussions
#1
Hi all,
I'm looking for suggestions on a system that would help us keep current on new and revised MEDDEVs.
We use a document center service for ISO, ASTM, BS, EN, ANSI, etc documents and receive an email from that service any time a document we have purchased from them has a new revision level. This triggers a document change internally so that we evaluate that new standard for changes and update our Documents of External Origin (and any related documents/testing) with that new standard.
However, we just received an audit nonconformance for not keeping MEDDEVs current and up-to-date on our Documents of External Origin.
As a corrective action, I'd like to institute a procedure but I can't think of any way to do this outside of stating we'd do a search for new MEDDEVs every X months, which doesn't seem like the best method to me.
Any other ideas for a system/procedure to keep current on the MEDDEVs?
(Side Note: I did argue with the auditor on the non-conformance that MEDDEVs are not standards, but interpretations of standards, and we had met the MDD requirements, but it didn't matter. We still received this as a minor non-conformance).
 
Elsmar Forum Sponsor

lboll

Involved In Discussions
#3
Thanks for the information, but going to a website like Emergo group to search is the reactive system we currently use. I was looking for something more that didn't require me to set a reminder every X weeks/months to conduct a search myself to look for the current MEDDEVs.
 
L

Lucasmf

#4
I've started using the RSS feeds from the source websites into Google Reader with pretty good success. For example I got the notice of the new Official Journal of the EU the day it released.

Not sure if MedDevs have their own feed but would be easy to confirm.
 
L

Lucasmf

#6
As a follow on note on Emergo. They have a LinkedIn group and a newsletter you can subscribe to where a lot of the info regarding changes get posted.
 

lboll

Involved In Discussions
#7
Thanks, everyone. These are all good ideas. I may just do them all and then there should be no way I'll miss the updates!
 
Thread starter Similar threads Forum Replies Date
R ISO 14001 - Determining and Keeping Current with Legal Requirements ISO 14001:2015 Specific Discussions 10
N Master Samples - What should we be keeping? IATF 16949 - Automotive Quality Systems Standard 9
U Manufacturing solutions and keeping records on quality Content CE Marking (Conformité Européene) / CB Scheme 3
Sidney Vianna Are the Accreditation Bodies doing their job? Keeping CB's accountable Registrars and Notified Bodies 0
A Alternative to keeping hard copy records that is 21 CFR part 11 compliant Document Control Systems, Procedures, Forms and Templates 0
S Employee Training Matrix - Keeping track of employee training on various SOPs ISO 13485:2016 - Medical Device Quality Management Systems 4
M Keeping up with "State-of-the-Art" & updated Standards EU Medical Device Regulations 11
S Keeping track of the changing Medical Device Standards Other Medical Device Related Standards 3
S Corporate Quality Manager keeping me out of the Management Review Meeting Management Review Meetings and related Processes 28
S Is not keeping inspection record an ISO 9001 nonconformity? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
knightarmourus Keeping the test samples in after market nlight alloy wheel production Manufacturing and Related Processes 2
A What is the definition of Installation that requires Record Keeping vs Set-up 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Implementing ISO 3834-2 - Keeping the organization informed Other ISO and International Standards and European Regulations 3
S Requirements for keeping Records in Electronic Format Records and Data - Quality, Legal and Other Evidence 15
D Keeping Same Medical Device Name but Changing Classification Medical Information Technology, Medical Software and Health Informatics 3
M Keeping Packaging Material and Photographs in Sync with Inventory Manufacturing and Related Processes 5
R FDA Rules and Requirements for Keeping Ink Signed Documents 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
M Quality Procedures - General Detail Level and Record Keeping Requirements Document Control Systems, Procedures, Forms and Templates 6
J Annual PPAPs - Keeping Up with Hundreds Of Customers And Hundreds Of Part Numbers APQP and PPAP 12
I Keeping up with changes to External Standards Document Control Systems, Procedures, Forms and Templates 8
T Keeping Track of Procedure Implementation Training Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Keeping Milk for Domestic Consumption Fresh - - Ideas? Coffee Break and Water Cooler Discussions 33
C Keeping Employees Updated on Newly Revised Procedures Document Control Systems, Procedures, Forms and Templates 15
A Document Relationship Matrix - Keeping Track of References to Related Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Wes Bucey Keeping your cool means keeping your job Career and Occupation Discussions 12
M Employee Turnover vs. Keeping up with Training Training - Internal, External, Online and Distance Learning 7
L 5S Auditing & Accountibility - Keeping our 5S tool boards complete and accounted for Lean in Manufacturing and Service Industries 13
J Keeping Gage R&R Samples Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
A Keeping Records of Competence of Employees Records and Data - Quality, Legal and Other Evidence 4
S Keeping Employee Self-Motivation Strong Human Factors and Ergonomics in Engineering 23
ScottK 15 year record keeping requirement? Components for Medical Devices Records and Data - Quality, Legal and Other Evidence 16
Casana Keeping old ISO certificates of registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Keeping up with all those changes! Document Control Systems, Procedures, Forms and Templates 5
B Keeping an External Auditor on because he's "useless"... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 55
Marc Paying Attention and Keeping Eyes Open - Girl Falls into Floor Funny Stuff - Jokes and Humour 4
R Keeping the Passion of an ISO9001 System - How to promote your QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
H Keeping Control of Controlled Documents Document Control Systems, Procedures, Forms and Templates 21
C Keeping ISO TS 16949 Certification During Forced Production Interruption IATF 16949 - Automotive Quality Systems Standard 2
B Keeping your Windows PC running Smoothly After Work and Weekend Discussion Topics 18
A Keeping prototype devices - Is there a regulatory or compendial requirement? ISO 13485:2016 - Medical Device Quality Management Systems 3
Wes Bucey Keeping the job and angling for promotion Career and Occupation Discussions 7
H Keeping a Stable Process for a company, any suggestions? Should I being doing more? Quality Tools, Improvement and Analysis 5
K Struggling with keeping part-time internal auditors in our program Internal Auditing 15
T Occurance of Non-Conformance, MRB (Material Review Board) and Record keeping Records and Data - Quality, Legal and Other Evidence 34
Marc Contract Firms Keeping Training Records Records and Data - Quality, Legal and Other Evidence 2
E Record Retention - NC for keeping records longer than our defined minimum Records and Data - Quality, Legal and Other Evidence 9
G Keeping Horses in the City Coffee Break and Water Cooler Discussions 13
apestate Keeping Procedures Simple - 15 person machine shop using text procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Starting Fresh or Keeping your QS procedures? IATF 16949 - Automotive Quality Systems Standard 3
D Mixed Product - Keeping one product from being mixed with similar product Misc. Quality Assurance and Business Systems Related Topics 12

Similar threads

Top Bottom