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When will ISO13485 Update be Released?

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R Update to ISO13485 / 14969 - Request for assistance from ISO/TC210 Working Group ISO 13485:2016 - Medical Device Quality Management Systems 2
M ISO13485:2016, MDSAP and Internal Audits ISO 13485:2016 - Medical Device Quality Management Systems 8
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
A Is it mandatory to obtain ISO13485 certificate prior to CE marking? EU Medical Device Regulations 8
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
A Document "Correspondence IATF 16949 vs ISO13485" available? IATF 16949 - Automotive Quality Systems Standard 0
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 8
N Can a (class I) medical device be manufactured in a GMP certified site with no ISO13485? EU Medical Device Regulations 18
V Iso13485 certification vs CE technical audit ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO13485:2016 7.5.6 Process Validation Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 1
D Customer Audit Finding ISO13485:2016 7.6 ISO 13485:2016 - Medical Device Quality Management Systems 7
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 6
R How to improve a Validation program and procedures to FDA (21 CFR part 820) & ISO13485 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S PPT for ISO13485:2016 Employee Training (Request) ISO 13485:2016 - Medical Device Quality Management Systems 0
qualityegghead ISO13485:2016 4.2.4 Control Of Documents - Lifetime of the Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
S Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness ISO 13485:2016 - Medical Device Quality Management Systems 13
C ISO13485 exclusions for design and automation company ISO 13485:2016 - Medical Device Quality Management Systems 2
R ISO13485/ISO9001 Convenient Document Management System Document Control Systems, Procedures, Forms and Templates 3
S ISO13485 2016 - What the upshot is of failing to upgrade on a medical diagnostic device ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO9001 & ISO13485 QMS for 2 types of products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M ISO13485 Documentation packs (manual, procedures, forms etc) ISO 13485:2016 - Medical Device Quality Management Systems 3
H ISO13485:2016 Measurement System - Methods General Measurement Device and Calibration Topics 4
C ISO13485/9001 clause 6.3 (Infrastructure) ISO 13485:2016 - Medical Device Quality Management Systems 3
G ISO13485:2016 Cl. 7.5.1 - Production and Service Provision - Medical Device Repairs ISO 13485:2016 - Medical Device Quality Management Systems 3
M Looking for Cross reference of AS9100:2016 to ISO13485 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M ISO13485:2016 - Exemption vs. Not Applicable ISO 13485:2016 - Medical Device Quality Management Systems 16
K Implementing ISO13485:2016 in the Middle of a New Device Project ISO 13485:2016 - Medical Device Quality Management Systems 1
T ISO13485:2016 Clause 6.3 - Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO13485:2016 Clause 4.2.3 - Changes in Technical File Requirements ISO 13485:2016 - Medical Device Quality Management Systems 18
T ISO13485 cert expired - Product still CE Marked CE Marking (Conformité Européene) / CB Scheme 1
V Revised ISO std vs ISO13485:2003 - Help Please!!! ISO 13485:2016 - Medical Device Quality Management Systems 4
C Is there a strong market out there for ISO13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 11
B Must a Design Outsourcing Company have ISO13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
L ISO13485 past practice labeling vs customer requirement Other ISO and International Standards and European Regulations 2
S CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Audits ISO 13485:2016 - Medical Device Quality Management Systems 7
Q Multiple Quality Standards - AS9100 and ISO13485/9001 Cross Reference Matrix Quality Manager and Management Related Issues 3
C ISO13485 Incoming Receiving Parts Verification ISO 13485:2016 - Medical Device Quality Management Systems 13
Q ISO13485 Section 7.5.1.1 and 7.5.2.1 for a Distributor ISO 13485:2016 - Medical Device Quality Management Systems 2
W Setting up from scratch - Looking for help (ISO9001 / ISO13485) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Outsource Production Line need ISO13485 Certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
somashekar Clause 7.5.5. as in the text and in the Annex B (ISO13485:2003) ISO 13485:2016 - Medical Device Quality Management Systems 1
U Do we have to have foreign legal documents? (ISO13485 4.2.3 document control) ISO 13485:2016 - Medical Device Quality Management Systems 3
0 Medical Device Distribution Centre and Implementing ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
C Writing a Sterilization Procedure when the Process is Subcontracted - ISO13485 Quality Management System (QMS) Manuals 1
J ISO13485 Certification Scope - Registering a Subset of our Products ISO 13485:2016 - Medical Device Quality Management Systems 9
J ISO13485 Clause exclusions for a Medical Software Company ISO 13485:2016 - Medical Device Quality Management Systems 9
P How to streamline different documents in a multi plant ISO13485 QMS ISO 13485:2016 - Medical Device Quality Management Systems 8
D FDA Guidance on Interim Use of ISO13485 for Medical Device Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3

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