Supply Agreement Regarding MDR 2017/745 - Manufacturer-supplier cooperation

K

kormach

Registered
#1
#1
Hello everyone,

I'm trying to update the Supply Agreement regarding to MDR 2017/745. It's not easy for me to gather all the requirements which may refer to manufacturer-supplier cooperation. I don't want to miss sth important. Maybe do you have sth like guideliness or even template with all necessary points? Thank you for your help in advance.
 
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
silentmonkey Are risks in supply chain and development activities within scope of MDD? EU Medical Device Regulations 3
N "Placing on the market" & "putting into service"- one time regulatory event or Continual supply event? EU Medical Device Regulations 2
B ASA Aviation Supply Association - Has anyone heard of ASA? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
G Do we need to QA cert? We only plan to supply reagents Medical Device and FDA Regulations and Standards News 3
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
E IEC 61010-1 Dielectric strength test of inner power supply Other ISO and International Standards and European Regulations 0
T Is anyone working with N299.1 (Supply/service to nuclear power plants)? Various Other Specifications, Standards, and related Requirements 0
Sidney Vianna Interesting Discussion How major corporations in the West keep failing to uphold their pledges of abolishing child labor in their cocoa supply chains Sustainability, Green Initiatives and Ecology 3
P Fan filter unit (un-ducted to air supply) vs fan filter unit (ducted to air supply) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
T Oversight of Distributors - Supply chain requirements under the MDR EU Medical Device Regulations 9
H External power supply - requirements in safety/EMC test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
O Inspecting paint and having workable standards in the supply chain Supplier Quality Assurance and other Supplier Issues 1
C Electrical Power Plant Supply failure in PFMEAs FMEA and Control Plans 10
O Supply chain strategy or commodity strategy reading recommendations Supplier Quality Assurance and other Supplier Issues 6
C SVHC Lead - Communicate in the supply chain under Article 33 of the REACH Regulation REACH and RoHS Conversations 1
N What should be included in the supply contract - Annex 2 list B IVD ISO 13485:2016 - Medical Device Quality Management Systems 6
G Supply Chain PPAP Requirements APQP and PPAP 10
M Is IEC 60601 compliance possible when only generic power-supply is specified? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
E Requirements for Humanitarian supply of Medical Devices to Jamaica Other Medical Device Regulations World-Wide 3
R Good Supply Practices that will be effective on March 1 2015 in China China Medical Device Regulations 2
T What Test Certificate should accompany supply of Cable XLPE/SWA/PVC 4CX150MM2 Document Control Systems, Procedures, Forms and Templates 2
B Detachable Power Supply Cable Connection ESD Clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
R Selling of Medical Power Supply in Australia/New Zealand and Japan Other Medical Device Regulations World-Wide 5
R Connection to a generic separate power supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
T EMC Tests - While certified power supply is part of device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B IEC 60950 power supply MOOPs IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
O IEC 61010-1 Ed 2: "Automatic Disconnection of the supply" CE Marking (Conformité Européene) / CB Scheme 3
O Can unit be categorized as EMI class A when it has EMI class B power supply in it? CE Marking (Conformité Européene) / CB Scheme 2
C Controls and Preventions are not "OJT", "Ample Supply" & "Supervisor Verification" FMEA and Control Plans 4
M ISO 13485 - Supply Chain Requirements ISO 13485:2016 - Medical Device Quality Management Systems 8
C "PEAK WORKING VOLTAGE" with a 220-240VAC nominal Power Supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
F Power supply certification and its effect on testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
AnaMariaVR2 Using ISO 9001 to Strengthen Supply Chain ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
W Supply Voltage Condition for Transformer O/L and S/C (open & short circuit) testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M IEC 60601-1 testing for device with its own 2V battery power supply necessary? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
somashekar Definition Supply and Erection / Supply and Commission - Technical Quotation Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
R Is it possible for medical power supply to declare CE based on MDD? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
AnaMariaVR2 Glaxo Sues Hospira Over Quality of Flu Vaccine Supply US Food and Drug Administration (FDA) 0
AnaMariaVR2 How The FDASIA Can Affect Your Supply Chain [article] Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
AnaMariaVR2 Finding a Common Language for Disaster-resistant Supply Chains Supply Chain Security Management Systems 1
S Class II PSU (200W) BF Power Supply Configuration Isolation Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Australian and New Zealand Standards - Supply Electricity MEN and TNC System Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
S Does the power supply need to be medical grade like the EU requires? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Wes Bucey Supply Chain Risk Assessment - Asia Floods Business Continuity & Resiliency Planning (BCRP) 1
B Requirement for ISO 9001 Flow Down to Supply Chain? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Medical Device Leakage Current Measurement with External Power Supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Stand-Alone Power Supply with Metal Enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
V External power supply with reinforced insulation as a simple secondary circuit? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
R Fuses that in series with each supply lead are only housed by Heat Shrink Tubing IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
L Supply Chain and Product Creation Process Improvement Quality Tools, Improvement and Analysis 1

Similar threads

Top Bottom