SBS - The best value in QMS software

MedMMAP Article - August 2018

Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R EU-MDR Article 9-common specifications Other ISO and International Standards and European Regulations 2
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
F Component maintenance qualification - Regulation (EU) No 1321/2014 Article 5 EASA and JAA Aviation Standards and Requirements 6
M Vigilance - incident found in an article EU Medical Device Regulations 3
dgrainger Informational MHRA guidance on CE UKNI - Article 5.5 - 2021-02 EU Medical Device Regulations 0
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
M MDR Article 22 Interpretation EU Medical Device Regulations 3
L EU MDR Article 86 PSUR EU Medical Device Regulations 1
K Article 18: Implant Card and information to be communicated. EU Medical Device Regulations 5
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
S Article 22 Procedure Pack Labelling EU Medical Device Regulations 4
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
S Translational Requirements - Article 120 EU Medical Device Regulations 5
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
K Expected lifetime of the device-Article 18 EU Medical Device Regulations 4
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 8
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 8
T Implant Card - Article 18.1(a) and MDCG 2019-8 clarification EU Medical Device Regulations 3
P Economic operator responsibilities - when the Importer is also Distributor - Article 13 EU Medical Device Regulations 1
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
K Article 18 in the Implant Card - Expected lifetime of the device EU Medical Device Regulations 3
S Article 61 - MDR Clinical Investigation Requirement EU Medical Device Regulations 5
C Article 16 MDR - Medicine packaged together with Medical Device EU Medical Device Regulations 0
F MDR system/procedurepack (article 22) with device acc. to MDD and MDR CE Marking (Conformité Européene) / CB Scheme 2
T Sample of 1st Article Inspection Report wanted APQP and PPAP 3
N EUDAMED postponement and compliance with Article 120 (3) MDR for Legacy Devices EU Medical Device Regulations 8
R MDR Article 22: Systems and procedure packs Other Medical Device Regulations World-Wide 12
T EU MDR Article 61- Clinical Evaluation EU Medical Device Regulations 2
F 2017/745 Article 31 Single Registration Number Medical Device and FDA Regulations and Standards News 5
Sidney Vianna Interesting Discussion Interesting article form the UNIDO Magazine - CSR: a wolf in sheep’s clothing? Sustainability, Green Initiatives and Ecology 16
M Informational EU – Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council o Medical Device and FDA Regulations and Standards News 2
M Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re Medical Device and FDA Regulations and Standards News 7
F Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements EU Medical Device Regulations 8
A Interpretation of Article 16 (2b) - Packaging, samples and Certificate EU Medical Device Regulations 10
E MDR Article 117 / Impact to New Marketing Authorization Applications Other Medical Device Regulations World-Wide 1
G First Article Submission (Destruction of parts) APQP and PPAP 2
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
K First Article Inspection (FAI) - Equipment used - Dimensions vs. Go/No-Go ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
T MDR article 22 - System of 2 CE products and validation / usability? EU Medical Device Regulations 10
C Is a First Article Inspection (FAI) Procedure required by ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Informational MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 Medical Device and FDA Regulations and Standards News 0
K Article 23 (Parts and components) - Economic Operator EU Medical Device Regulations 1
Marc As the earliest wind farms age - Dec 2018 Ars article Sustainability, Green Initiatives and Ecology 4
T Clarification on MDR - Article 18(d) - Implant Card EU Medical Device Regulations 14
Sidney Vianna Interesting Discussion Article from Grant Ramaley in QD - MDSAP: When Is a Certificate Not a Certificate? Canada Medical Device Regulations 0
M FAI AS9102 - What does a First Article Inspection cover? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
C AS9100, Clause 8.5.1.3 - First Article Inspection Costs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16

Similar threads

Top Bottom