Implantable Medical Device Consignment Stock - What to consider?

Aphel

Involved In Discussions
#1
Dear all,

Actually my company (distributor of implant medical devices) is going to install a consignment stock at the customers place.
(customer = hospital)

What do I need to consider from quality point of view?

Thank you very much in advance for all hints and comments!

Best regards,
Aphel
 
Elsmar Forum Sponsor

Aphel

Involved In Discussions
#4
Hello!

Has anybody an example of a consignment contract which is possible to share? I am not interested in the legal parts, but in the quality related parts...

Thanks in advance for any feedback!

BR
Aphel
 
Thread starter Similar threads Forum Replies Date
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
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
R Cable used in Active Implantable Medical Device Other Medical Device and Orthopedic Related Topics 4
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
E Labeling Requirements for an Implantable Medical Device Distributor 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
D Implantable Medical Device (Silicone Implant) Regulations for Thailand & Mexico Other Medical Device Regulations World-Wide 13
M Informational EU – DSVG 03 – Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
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
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
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
F Traceability Requirements for Implantable Medical Devices Other Medical Device Regulations World-Wide 2
M Required Genotoxicity Tests for Implantable Medical medive Other Medical Device and Orthopedic Related Topics 1
T Biocompatibility Testing for Implantable Medical Devices according to ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 4
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
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
R Is Biocompatibility Testing required for Implantable Class III Devices sent to China China Medical Device Regulations 3
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
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
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
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
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
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
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
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

Similar threads

Top Bottom