Gap assessment comparing RDC ANVISA 665/2022 and RDC ANVISA 16/2013?

Y

YellowQCPro

Involved In Discussions
Does anyone in the Cove have a gap assessment comparing RDC ANVISA 665/2022 and RDC ANVISA 16/2013?

Thank you.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Complex IEC 60601-1 gap assessment IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S EU MDR CAPA - GAP Assessment on CAPA SOPs EU Medical Device Regulations 1
M Canadian regulation gap assessment Canada Medical Device Regulations 7
R New Tool from Omnex - IATF Gap Assessment IATF 16949 - Automotive Quality Systems Standard 0
W Gap Assessment for TS 16949 to IATF 16949 IATF 16949 - Automotive Quality Systems Standard 11
Q Gap assessment on TL9000 with respect to ISO TS 16949 TL 9000 Telecommunications Standard and QuEST 3
S Security Gap Assessment Methodology based on ISO 27001 or COBIT IEC 27001 - Information Security Management Systems (ISMS) 1
R ISO 27001 Gap Assessment content vs. Risk Assessment Other ISO and International Standards and European Regulations 2
L Initial ISO 9001 Status Assessment (Gap Analysis) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S ISO 9000:2000 to TS 16949:2000 Gap Assessment Tool IATF 16949 - Automotive Quality Systems Standard 2
C IMS Gap analysis Occupational Health & Safety Management Standards 0
E ISO9001:2015 to IATF16949 Gap Analysis???? IATF 16949 - Automotive Quality Systems Standard 3
S ISO 14001:2015 Gap Analysis Resources ISO 14001:2015 Specific Discussions 3
Vader22 FORD CSR Gap Analysis Checklist IATF 16949 - Automotive Quality Systems Standard 4
B ISO 9001:2015 vs ISO 13485:2016 Gap analysis ISO 13485:2016 - Medical Device Quality Management Systems 9
Ashland78 Need IATF 16949 ISO Gap Analysis Excel File Internal Auditing 3
O Quality Management System Implementation framework and Gap analysis checklist Manufacturing and Related Processes 7
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1
JoCam MDR Gap Analysis - Consultant fees EU Medical Device Regulations 10
R Gap Audit Aerospsace and Rail QMS Quality Manager and Management Related Issues 3
M MDSAP and 13485:2016 gap analysis Quality Management System (QMS) Manuals 1
M Gap analysis on ISO 14971:2019 with previous revision ISO 14971 - Medical Device Risk Management 12
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
J Looking for a EU MDR Gap Analysis template EU Medical Device Regulations 6
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
M 10993-11 vs 2006 gap analysis Other Medical Device Related Standards 2
Nicole Desouza AS 9100 Rev D Gap Analysis AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R AS9100 REV D gap analysis matrix AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M MDR Medical devices Gap analysis ISO 13485:2016 - Medical Device Quality Management Systems 2
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
J ISO 9001:2015 Excel Gap Analysis wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
E ISO TC 34 and ISO 22000:2018 Gap Analysis and the principles of Codex Alimentarius Food Safety - ISO 22000, HACCP (21 CFR 120) 1
shimonv Checklist for MDD to MDR gap analysis EU Medical Device Regulations 23
Q GAP Analysis between IATF 16949 and VDA 6.3 wanted VDA Standards - Germany's Automotive Standards 4
Y Time gap for First Surveillance Audit of AS9100D after initial certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
P ISO 14001 - Looking for a Gap Analysis Template ISO 14001:2015 Specific Discussions 3
S Gap Analysis MDR req/MEDDEV 2.7.1 rev 4 EU Medical Device Regulations 3
V How do I get a rough MDD to MDR gap analysis by clauses Other Medical Device Related Standards 5
C Annex II EU MDR gap analysis EU Medical Device Regulations 7
P ISO 14155 GAP analysis Other Medical Device Related Standards 3
T IEC 60601 3.1 edition Gap Analysis wanted IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J PCI PIN compliance and Gap analysis IEC 27001 - Information Security Management Systems (ISMS) 0
B Gap analysis of new start-up company technical documentation CE Marking (Conformité Européene) / CB Scheme 1
S ISO 9001:2015 Gap Analysis - In-House or 3rd Party? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
O What does "Gap" and "Flush" in ASME Y14.5 mean? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S TGA regulations and ISO 13485:2016 gap analysis MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 2
B NEED HSE-MS Gap Analysis between 2 existing Management Systems Occupational Health & Safety Management Standards 0
F New to RA: FDA Regulation Checklist/Gap Analysis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Cats Clause Upgrading from ISO 9001:2015 to IATF 16949:2016 - Anyone have a gap analysis tool? IATF 16949 - Automotive Quality Systems Standard 2
K AS9100 Rev. D Transition - Internal Audits & Gap Analysis Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14

Similar threads

Top Bottom