Contract Manufacturer as Design Owner ISO 13485

HnZul

Starting to get Involved
#1
Hi!
Can a contract manufacturer have an ISO 13485 certified with scope: "Design and development, manufacture of XYZ medical device"?
We could have our own design and customer design as well.
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
yes, it could if it also has the capability to design products to its name or per someone else's specifications.
 

HnZul

Starting to get Involved
#3
Thank you shimonv! Then, is it a need for us to write the ISO 13485 certificate scope as "Design and development, manufacturing, contract manufacturing and distribution of XYZ medical device"? or we can just exclude the Contract Manufacturer in our scope
 

shimonv

Trusted Information Resource
#4
whether you are a legal manufacturer or a contract manufacturer, it is essential the same thing from ISO prospective - you need to have manufacturing and process controls. In my opinion, there is no need for the contract manufacturing.
 

somashekar

Staff member
Admin
#7
Thank you shimonv! Then, is it a need for us to write the ISO 13485 certificate scope as "Design and development, manufacturing, contract manufacturing and distribution of XYZ medical device"? or we can just exclude the Contract Manufacturer in our scope
XYZ medical devices in your case must be the same in terms of being within the medical device family (see 3.12)
If not the case, then there is no harm in the split scope.
The scope in the certificate must be giving such clarity.
Additional details can be provided in the quality manual appropriately, as the organization shall document the roles undertaken under the applicable regulatory requirements. (see 4.1.1)
 
Thread starter Similar threads Forum Replies Date
S Is it okay to store the design files (device drawings) at contract manufacturer location? ISO 13485:2016 - Medical Device Quality Management Systems 6
R Sterilization Adoption - Design House - Adoption Letter from Contract Manufacturer EU Medical Device Regulations 3
R Process Development Requirements for a Contract Manufacturer with no Design Design and Development of Products and Processes 5
R Design History File DHF Practices and Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L Can this Contract Manufacturer exclude Clause 7.3? Design and Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
I Is SRN required for a contract manufacturer (CE-Marking product)? EU Medical Device Regulations 2
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 4
shimonv Working with a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
S Who is technically and legally a "Contract Manufacturer"? ISO 13485:2016 - Medical Device Quality Management Systems 4
E Component manufacturer or contract manufacturer ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 11
H 510k with Contract Manufacturer Other US Medical Device Regulations 2
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
M We are looking for a Contract Manufacturer US Food and Drug Administration (FDA) 2
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
I Is the contract mfg. mentioned in legal manufacturer EC certificate? CE Marking (Conformité Européene) / CB Scheme 4
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 1
M Contract manufacturer MDR Quality Management System (QMS) Manuals 1
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Medical Device Master File - We are a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 10
D Software Validation - Contract manufacturer of Components (PCBA's) Qualification and Validation (including 21 CFR Part 11) 7
J Contract Sterilization - Our company is a contract manufacturer Manufacturing and Related Processes 8
R Contract Manufacturer/OEM Supplier - We are a specification developer for a kitted product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
leftoverture REACH Compliance - Small, family-owned contract manufacturer REACH and RoHS Conversations 16
R 21 CFR Part 820 Contract Manufacturer of Medical Device Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Ed Panek Bringing Production in house from Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 80079-34 certified contract manufacturer needed Other ISO and International Standards and European Regulations 2
Ed Panek Observational Audit of Contract Manufacturer Production ISO 13485:2016 - Medical Device Quality Management Systems 5
M Contract Manufacturer of a Finished Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
D EU MDR - Contract Manufacturer vs Legal Manufacturer EU Medical Device Regulations 4
I Certificate of Exportability - Contract manufacturer located outside the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Is company “A” a contract manufacturer, a labeler, or a repackager 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Integrating a Contract Manufacturer's documentation into our Quality System ISO 13485:2016 - Medical Device Quality Management Systems 3
J Medical Devices sourced from Contract Manufacturers - Who is the legal manufacturer? EU Medical Device Regulations 13
S Question about ISO 13485:2003 - Production Provisions - Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 10
S Contract Manufacturer Question - Whether or not the reference to the ex-CMO ISO 13485:2016 - Medical Device Quality Management Systems 6
Ajit Basrur Can a Contract Manufacturer Delist a Device upon Discontinuation of Manufacturing? Other US Medical Device Regulations 1
H Who is the Legal / Labeled Manufacturer? (Contract Manufacturers shipping to the EU) ISO 13485:2016 - Medical Device Quality Management Systems 1
N "Sterile" missing on the CE Certificate - ISO 13485 Certified Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 5
N UDI implementation with contract manufacturer Other US Medical Device Regulations 2
somashekar Pre-Announced FDA 4 Day Inspection, Class 2 Devices, Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
W Shared Responsibility Between Spec Provider and Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Device Master Records for a Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N FDA - Change of Manufacturings Site to Contract Manufacturer in China 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4

Similar threads

Top Bottom