Medical device CER (clinical evaluation report) training/seminar services

Elsmar Forum Sponsor

QM_123

Starting to get Involved
#3
Sometimes notified bodies and quality consultancy companies arrange this kind of training, it will be better if you check the related institutions around your location.
 
Thread starter Similar threads Forum Replies Date
P Adding "new" medical device to existing CER - under MDD CE Marking (Conformité Européene) / CB Scheme 1
S Medical device CER (clinical evaluation report) according to MDR EU Medical Device Regulations 10
H CER - Considering similar device/other medical devices for as relevant literature CE Marking (Conformité Européene) / CB Scheme 4
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 7
T Loaded spring device - Active medical device? EU Medical Device Regulations 1
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 2
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 3
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
E IEC 60601-1 - Unearthed Medical Device Metal Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Medical Device Registration in the UAE MoH Other Medical Device Regulations World-Wide 2
JoCam Medical Device Distribution in the UK EU Medical Device Regulations 6
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Direct to customer export of medical device (class I: prescription lenses + frame) US Food and Drug Administration (FDA) 2
J Validity / outcomes measure for custom made medical device ISO 13485:2016 - Medical Device Quality Management Systems 2
S Regulatory job in pharma vs. medical device US Food and Drug Administration (FDA) 16
S Regulatory job in pharma vs. medical device CE Marking (Conformité Européene) / CB Scheme 0
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 1
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
Q 21 CFR 821 Medical Device Tracking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Discontinuation of the Predicate Medical Device Medical Device and FDA Regulations and Standards News 1
H Online courses/program for medical device regulation EU Medical Device Regulations 4
T EQMS for small medical device company ISO 13485:2016 - Medical Device Quality Management Systems 8
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
P Manufacturing equipment (e.g.: Dental Welder): medical device or not? US Food and Drug Administration (FDA) 5
JoCam False information provided for Medical Device Registration - What are the implications? Other Medical Device Related Standards 3
M Status of Medical Device Regulations in UK Post-Brexit Other Medical Device Regulations World-Wide 8
S Contagious Diseases in Medical Device Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 5
S How to register class IIA medical device accessories EU Medical Device Regulations 1
D 3 Companies - Medical device parts and substances - Responsibilities EU Medical Device Regulations 4
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
N Post registration variation to medical device Other Medical Device Regulations World-Wide 1
Similar threads


















































Top Bottom