Supplier of design and manufacture process

Biomedical_engeener

Starting to get Involved
#1
I got really confused and lost between my own thoughts with this one.

We manufacture custom made medical devices ( including design process) but there is company who would like us to manufacture their designs as they do not have MDR certification.
In this case, would they be our suppliers ? if so, what are ISO 13485 and MDR requirements which we, as manufacturers, need to follow ? Chapter 7.4. Purchasing of ISO ?
Or are we their supplier ?

Many thanks for any help.
 
Elsmar Forum Sponsor

ScottK

Not out of the crisis
Staff member
Super Moderator
#2
It looks like they are asking you to be the contract manufacturer, in which case you are the supplier.
But even if you are the CM, if this customer is marketing it the registration will be in their name.
Overall MDR responsibility would be with the customer - even though your organization is doing the bulk of the work.
You should have a quality agreement with the customer that details responsibilities.
 

Biomedical_engeener

Starting to get Involved
#3
It looks like they are asking you to be the contract manufacturer, in which case you are the supplier.
But even if you are the CM, if this customer is marketing it the registration will be in their name.
Overall MDR responsibility would be with the customer - even though your organization is doing the bulk of the work.
You should have a quality agreement with the customer that details responsibilities.

Thanks ScottK !
They do not have MDR certification, so I think, they can't sell it under their name. Can they?
From what we spoke with them, it would be under our name, but they would do the design part.
The responsibility would be with manufacturer from what you say but do they take responsibility for correct design if we include in the arrangement ?Would quality agreement be enough ?
Many thanks!
 

Biomedical_engeener

Starting to get Involved
#5
Our company name will be on the label as the other company doesn't have MDR certificate. What I understand, they cant put anything on the market without MDR certification.
 

William55401

Involved In Discussions
#6
Thank you. In my view, the other org is a Design Service provider that must be under your firm's supplier controls. As your firm is putting your name on the product, your firm carries the regulatory approval responsibility and the associated risks with post market performance monitoring and action.
 

Biomedical_engeener

Starting to get Involved
#7
Many thanks William55401.
Would agreement/ quality agreement be enough ?
Is it designer (supplier) responsibility for the design if we will include it in the agreement or should we check every single design ( we do custom made devices)
 

William55401

Involved In Discussions
#8
A quality agreement is key. It will determine how deep you go into their design process. Will your team review and approve certain deliverables? Who picks suppliers? Within the quality agreement, I would pay special attention to the risk management space as design drives the downstream production and process (including supplier) controls.
 

James

Involved In Discussions
#10
I got really confused and lost between my own thoughts with this one.

We manufacture custom made medical devices ( including design process) but there is company who would like us to manufacture their designs as they do not have MDR certification.
In this case, would they be our suppliers ? if so, what are ISO 13485 and MDR requirements which we, as manufacturers, need to follow ? Chapter 7.4. Purchasing of ISO ?
Or are we their supplier ?

Many thanks for any help.
I think contract manufacturer would be correct, but the device file would be a joint endeavor. You would need to be clear about accountabilities in your agreement with them. If the device fails, who is accountable? Presumably if it was made correctly to their incorrect design, some fault would lie with them, but as the manufacturer you may bear the burden of accountability. This obviously depends on other factors too; the risks involved with the product, etc. Just my view.
 
Thread starter Similar threads Forum Replies Date
Shawn Mosby DFMEA when the supplier doesn't have design responsibility APQP and PPAP 14
C Partial Design Validation and changes to a critical supplier 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Comparative Design of Experiment to pick better Trimming Blade Supplier Six Sigma 5
G AS9102 Design Supplier Part Number vs. Customer Part Number AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
Q Supplier Design Review Worksheet from a customer Supplier Quality Assurance and other Supplier Issues 1
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 2
M How Supplier Capacity check is done by competitors Manufacturing and Related Processes 0
C One Time Service Supplier - Temperature and Humidity Testing Service ISO 13485:2016 - Medical Device Quality Management Systems 5
M Supplier Audits - Stop Wasting Everyone's Time! General Auditing Discussions 15
G Supplier management when the supplier is your headquarter IATF 16949 - Automotive Quality Systems Standard 3
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
D List A IVD - Change to material supplier EU Medical Device Regulations 3
J Minimum Supplier Certifications for Food Supplements Food Safety - ISO 22000, HACCP (21 CFR 120) 2
R Supplier/Vendor Surveys (360) Supplier Quality Assurance and other Supplier Issues 1
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
B AS9100 8.4.1 Supplier Selection/Evaluation criteria and reevaluations AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 13
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Supplier Audit Report - Template for second party audit wanted Lean in Manufacturing and Service Industries 1
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
Ed Panek Corona Virus impact on Supplier Audits and Received Parts ISO 13485:2016 - Medical Device Quality Management Systems 4
NDesouza Verification of Supplier RCCAs Nonconformance and Corrective Action 5
K Supply Agreement Regarding MDR 2017/745 - Manufacturer-supplier cooperation Other Medical Device Related Standards 0
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
P Supplier Audits in the wake of COVID-19 ISO 14971 - Medical Device Risk Management 2
T Ideas for developing a Supplier Quality Management System, non automotive ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Vendor (Supplier) Evaluations and Reports Supplier Quality Assurance and other Supplier Issues 11
F Is there such a thing as 'Critical supplier' status under the Dept. of Health (UK)? Medical Device and FDA Regulations and Standards News 2
A MSA results differences - Supplier results vs. My results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
G Supplier flowdown verification of tests and revisions Supplier Quality Assurance and other Supplier Issues 0
S Software for Supplier Charge back and internal PPM General Information Resources 2
R IATF/IAOB Red Supplier Pilot Program IATF 16949 - Automotive Quality Systems Standard 1
M Changing supplier of critical raw material (III class device) Other Medical Device and Orthopedic Related Topics 1
S VW Supplier Product Safety Representative (PSB) upgrade to PSCR VDA Standards - Germany's Automotive Standards 3
S Process Map for Supplier Process Maps, Process Mapping and Turtle Diagrams 5
D Licensee as a Supplier on the ASL Medical Device and FDA Regulations and Standards News 10
R Definition Key Supplier - Definition of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
shimonv Rigid rules for handling supplier audit findings ISO 13485:2016 - Medical Device Quality Management Systems 11
G Supplier Checking With Gauge Pin Problem Solving, Root Cause Fault and Failure Analysis 2
R AS9100 DELTA FAI - Sub-supplier for plating changed AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
P IATF 16949 8.4.2.4 Supplier Monitoring IATF 16949 - Automotive Quality Systems Standard 2
A Supplier Quality Standard vs Senior Management Direction Supplier Quality Assurance and other Supplier Issues 2
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
R Supplier evaluation and business needs in the context of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
J IATF 16949 8.4.1.2 Supplier selection process IATF 16949 - Automotive Quality Systems Standard 4
Q Supplier audit question cataloque VDA Standards - Germany's Automotive Standards 0
Ed Panek Inactive key supplier question - We are not actively buying from them ISO 13485:2016 - Medical Device Quality Management Systems 2
Ajit Basrur Quality Agreement with supplier covering medical devices and consumer requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
Similar threads


















































Top Bottom