SBS - The best value in QMS software

Medical Device NBs - Loaded up - December 2016

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M (medical device) V&V phase: justification of acceptance criteria (statistical method ?) Design and Development of Products and Processes 0
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 1
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
M Medical device substance based-leachables Other Medical Device Related Standards 2
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
T B2C Medical Device Shipping across the US Other Medical Device Related Standards 0
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 7
L Medical device storage conditions ISO 13485:2016 - Medical Device Quality Management Systems 1
F USB powered handheld medical device - Isolation requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
L How to determine / validate Medical Device Storage Conditions ISO 13485:2016 - Medical Device Quality Management Systems 1
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required ? Other Medical Device Regulations World-Wide 3
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 6
A Medical device Mode Of Action CE Marking (Conformité Européene) / CB Scheme 2
P Best Global Option to become an OBL/PLM/Virtual medical device brand in 2020 Other Medical Device Regulations World-Wide 2
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
S Philippines CMDL (Certificate of Medical Device Listing) Elsmar Cove Forum ToS and Forum Policies 0
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
J UCLA extension Medical Device Engineering Program Training - Internal, External, Online and Distance Learning 0
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 3
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020) US Food and Drug Administration (FDA) 6
A Legal Manufacturer Medical device US Food and Drug Administration (FDA) 2
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 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

Similar threads

Top Bottom