Informational EU published new Harmonised Standards List for the Directives (25/3/2020)

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
A Timeline for harmonised standards to be published under MDR CE Marking (Conformité Européene) / CB Scheme 5
G New list (01-2013) of Harmonised Standards for The MDD published EU Medical Device Regulations 18
dgrainger Informational UK guidance on FSNs - Published 20 May 2020 Other Medical Device Regulations World-Wide 1
Richard Regalado ISO 22301:2019 has been published - Nov 2019 Business Continuity & Resiliency Planning (BCRP) 0
W Informational VDI 2017 - Medical Grade Plastics - German VDI has published a "Richtlinie" Other Medical Device Related Standards 1
M Informational Team-NB published a press release regarding the survey run among its members to analyse the certificates being issued Medical Device and FDA Regulations and Standards News 0
M Informational EU – Corrigenda for MDR and IVDR published in Official Journal Medical Device and FDA Regulations and Standards News 0
M Informational Corrigendum for the EU IVDR Published Medical Device and FDA Regulations and Standards News 0
M Informational Corrigendum for the EU MDR Published Medical Device and FDA Regulations and Standards News 0
M Informational Team-NB published a press release regarding the capacities of notified bodies to meet the sector needs Medical Device and FDA Regulations and Standards News 0
M Medical Device News Medical Device Directives – New templates for Field Safety Notices published Medical Device and FDA Regulations and Standards News 0
M Medical Device News Novas normas publicadas pelo ABNT/CB-026 / New standards published by ABNT/CB-026 Medical Device and FDA Regulations and Standards News 0
M Is there a published List of AIAG members requiring IATF certification ? IATF 16949 - Automotive Quality Systems Standard 2
M Medical Device News New guidance sheets for the MDR/IVDR published EU Medical Device Regulations 0
planB ISO 10993-1:2018 has just been published Other Medical Device Related Standards 2
Richard Regalado ISO 31000:2018 is now published! Risk Management Principles and Generic Guidelines 0
bio_subbu CAMD published FAQs to the transitional provisions of MDR and IVDR EU Medical Device Regulations 0
Ajit Basrur Informational ISO/IEC 17025:2017 Published - November 2017 ISO 17025 related Discussions 8
M MDR and IVDR to be published May 5th 2017 EU Medical Device Regulations 14
S Use of Published IMDS Data from our Raw Material Supplier RoHS, REACH, ELV, IMDS and Restricted Substances 6
SteveK 'Clean' Draft Medical Device Regulations Published EU Medical Device Regulations 0
M MEDDEV 2.7/1 rev.4 published - June 2016 EU Medical Device Regulations 41
bio_subbu Official Journal of EU published two new RoHS Exemptions EU Medical Device Regulations 1
M IEC 62366-1 published - March 2015 IEC 62366 - Medical Device Usability Engineering 7
T When will IEC 60601-1-2 Ed.4 be published? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M EN ISO 60601-2-22:2013 hasn't been published in OJEU yet Quality Manager and Management Related Issues 11
G What are the changes in the BS EN 1041:2008 recently published amendment Other Medical Device Related Standards 11
SteveK Unannounced Audits - Commision Recommendation 2013/473/EU Published 25.9.2013 CE Marking (Conformité Européene) / CB Scheme 6
bio_subbu Eucomed published guidance document on RoHS 2.0 EU Medical Device Regulations 13
I New AIAG CQI guidelines published - Are they worth buying? Misc. Quality Assurance and Business Systems Related Topics 2
Sidney Vianna EMS auditor competence ISO Standard published - ISO/IEC TS 17021-2:2012 Miscellaneous Environmental Standards and EMS Related Discussions 1
S EU Medical Devices (Amendment) Regulations 2012 have been published EU Medical Device Regulations 2
Richard Regalado ISO 22301 was published 2012 May 15 - New Standard for BCM - Published! Business Continuity & Resiliency Planning (BCRP) 2
W MEDDEV: Qualification and Classification of Stand Alone Software Published EU Medical Device Regulations 4
AnaMariaVR2 GMP News: New Version of ISO 19011 on Auditing published Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
D Is ISO/TS 16949:2009 due for review and new edition to be published in 2012? IATF 16949 - Automotive Quality Systems Standard 6
RoxaneB Just been published! Coffee Break and Water Cooler Discussions 23
P New Renault CSR just published on the IATF Global Oversight webpage Customer and Company Specific Requirements 0
chris1price The final version of the RoHS2 recast was published last week as 2011/65/EU RoHS, REACH, ELV, IMDS and Restricted Substances 8
W MDDS Final Rule Published - February 15, 2011 US Food and Drug Administration (FDA) 0
bio_subbu CDSCO Published Draft version of Medical Devices Guidance Documents Other Medical Device Regulations World-Wide 3
bio_subbu Egyptian MOH published ?Draft Regulation for Medical Devices? Other Medical Device Regulations World-Wide 2
bio_subbu Eucomed published revised guideline on Good Distribution Practice ISO 13485:2016 - Medical Device Quality Management Systems 3
M IEC 60601-1-11 MEE used in Home Healthcare Environment Published IEC 60601 - Medical Electrical Equipment Safety Standards Series 21
R ISO 10993-1:2009 incorporating Risk Management published by ISO ISO 13485:2016 - Medical Device Quality Management Systems 1
somashekar Revisions to the MDD 93/42/EEC published as Directive 2007/47/EC EU Medical Device Regulations 5
I IEC/TR 80002-1 Medical Device Software Part 1 has been published Other Medical Device Related Standards 7
bio_subbu Australia?s TGA - IVD Regulations have been published Other Medical Device Regulations World-Wide 0
M ISO 13485:2003 / Corrigendum 1:2009 has been published - Free! ISO 13485:2016 - Medical Device Quality Management Systems 9
K About laboratory scopes published correctly from your accreditation body General Measurement Device and Calibration Topics 1
Similar threads


















































Top Bottom