Informational EU – DSVG 03 – Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices

Thread starter Similar threads Forum Replies Date
M Informational DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
G Is cardiac waveform generator a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Simulated Use Cardiac Catheter Test Fixture Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
T Multiple Applied Parts - Cardiac Floating (CF), Body Floating (BF) Marking EU Medical Device Regulations 3
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
M Informational Health Canada – Guidance Document: Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing Medical Device and FDA Regulations and Standards News 0
R Applicability of ISO 14708-3 RF Transmitter and Implantable RF Receiver Other Medical Device Related Standards 1
R Applicability of ISO 14708-3 - RF transmitter and implantable RF receiver Other Medical Device and Orthopedic Related Topics 1
J0anne Implantable Devices - The effects of surgical scaffold implanted into the human body Other Medical Device and Orthopedic Related Topics 8
M Entering the Italian Market - Implantable Medical Device EU Medical Device Regulations 1
I Implantable medical device cleaning validation Other Medical Device Related Standards 3
D Ethylene Oxide Sterile Implantable Medical Device Shelf Life Extension Other Medical Device Related Standards 1
L Implantable Medical Device Manufacturer Going Out of Business - Complaints EU Medical Device Regulations 2
A Active Implantable Medical Devices - Legal Traceability Requirements ISO 13485:2016 - Medical Device Quality Management Systems 7
Marc A silk casing enables long-lasting, implantable Wi-Fi medical devices Other Medical Device and Orthopedic Related Topics 1
A Implantable Medical Device Consignment Stock - What to consider? ISO 13485:2016 - Medical Device Quality Management Systems 3
R Cable used in Active Implantable Medical Device Other Medical Device and Orthopedic Related Topics 4
J Use of expired perminant implantable sterile medical products ISO 13485:2016 - Medical Device Quality Management Systems 2
A Pre-clinical Animal Studies for long term implantable medical devices EU Medical Device Regulations 5
R Is Biocompatibility Testing required for Implantable Class III Devices sent to China China Medical Device Regulations 3
E FDA Requirements for Implantable Medical Device Software Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
E Defining the lifetime of an Implantable Medical Device Other Medical Device and Orthopedic Related Topics 5
J Risks Analysis of an Active Implantable Muscle Stimulator ISO 14971 - Medical Device Risk Management 8
P What does 'Shelf Life' of Sterile Implantable Orthopaedic Devices mean? ISO 13485:2016 - Medical Device Quality Management Systems 5
E Applicability of Defibrillator Energy Test to Implantable Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
E Labeling Requirements for an Implantable Medical Device Distributor 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Ronen E Medtronic recalls some Implantable Cardioverter Defibrillators Other Medical Device and Orthopedic Related Topics 2
JanWarner Nonconforming Implantable Dental Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
P Risk Assessment Production Process Milling for Implantable Joints EU Medical Device Regulations 2
D Windows CE Operating System - Implantable Blood Pump and a Software Accessory Device IEC 62304 - Medical Device Software Life Cycle Processes 8
G Double Blister Pack for an Implantable Device Other ISO and International Standards and European Regulations 1
D Implantable Medical Device (Silicone Implant) Regulations for Thailand & Mexico Other Medical Device Regulations World-Wide 13
F Traceability Requirements for Implantable Medical Devices Other Medical Device Regulations World-Wide 2
C Non Absorbable Sutures - Implantable Device or Long-Term Surgically Invasive Device? CE Marking (Conformité Européene) / CB Scheme 6
R Implantable Drug Delivery System (IDDS) - Manufacturers C of A Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Software Validation - Pre submission for an implantable 'surgical mesh' device Qualification and Validation (including 21 CFR Part 11) 5
W Biocompatibility of Implantable Component - What testing, if any? Other Medical Device and Orthopedic Related Topics 5
M Required Genotoxicity Tests for Implantable Medical medive Other Medical Device and Orthopedic Related Topics 1
T Sterilization of Implantable bone screws - ISO 13485 and CE Mark EU Medical Device Regulations 14
G New intended use - Validation of a class IIb implantable (non-active) ISO 13485:2016 - Medical Device Quality Management Systems 5
T Biocompatibility Testing for Implantable Medical Devices according to ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 4
J Requirements for Implantation Records/Cards - Class III, Implantable (not active) ISO 13485:2016 - Medical Device Quality Management Systems 1
Q Can Exclusions be Made in QMS Manual - We make NO implantable devices Quality Management System (QMS) Manuals 1
M Particulate On Final Implantable Devices ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom