ISO 13485 Risk Management for Contract Manufacturer

T

treesei

#11
"Only one of the parts can be considered an end product: it is intended for implant but the OEM does all the sterilization, packaging and labeling."

This puts this client under FDA regulation (if the part is used in US) or 13485 (if used in many other countries). The part is already a finished device per FDA definition. Hope the client has registered with the FDA if product is used in US.

Am I wrong?
 
Elsmar Forum Sponsor
M

MIREGMGR

#12
I'm not sure of your intent with regard to the word "client", so let's use "contract manufacturer" for the company that does the machining.

Per http://www.fda.gov/cdrh/registration/whomust.html, a contract manufacturer that does not participate in marketing the product they manufacture, whether that product is a finished medical device (i.e. ready to market) or requires further manufacturing steps before it is ready to market (for instance, sterilization, packaging and/or labeling), is not required to register their establishment and not required to list (on the FDA DRLM website) the products they make.

The company that markets the finished product has primary responsibility for all aspects of manufacturing, and is expected to control that manufacturing through their contract with the contract manufacturer.

The company that markets the product has responsibility for premarket notification or approval, as applicable.

The company that markets the product has responsibility for post-market vigilance and any associated reporting requirements.

The contract manufacturer has co-responsibility for those aspects of the product creation process over which they have some degree of direct control, either practically or by contractural agreement. The contract manufacturer may be inspected if an inspection of the product marketer gives rise to questions regarding the manufacturing process, or if a field issue arises in regard to the product they make.
 
M

MarvL

#13
I work for a medical device component supplier. We do not make any user products. I am responsible for preparing the company for an ISO 13485 audit (currently ISO 9001 certified) and struggling over what we should considered as risk.

From a design perspective, our inputs to the customer are within the scope of manufacturability. Design development and validation requirements are defined and driven by the customer. The medical device health hazard risks and mitigation are owned by the customer and reflected/linked to the component print and/or spec controls.

My conclusion is that supplier risk is controlling our materials procurement, manufacturing, labeling, and shipment. So therefore supplier risk can be simplified to be processes to meet the customer prints and/or specification.

Is this an accurate assessment of supplier risk?
 

somashekar

Staff member
Super Moderator
#14
My conclusion is that supplier risk is controlling our materials procurement, manufacturing, labeling, and shipment. So therefore supplier risk can be simplified to be processes to meet the customer prints and/or specification.
You are OK...
Consider risks to patient and user
Discuss your risk assessment with your customer, and get value added feedback from him being the one responsible for the device risks.
 
Thread starter Similar threads Forum Replies Date
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 5
S ISO 13485:2016 - Risk-based Approach ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 13485:2016 - How I can integrate a risk management approach in our SOPs ISO 13485:2016 - Medical Device Quality Management Systems 1
S Risk Based Approach for ISO 13485:2016 Form/Procedure ISO 13485:2016 - Medical Device Quality Management Systems 23
A Including all Processes in Risk Management - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 8
T Struggling with ISO 13485:2016 Clause 6.2 - Level of Risk Associated with Work ISO 13485:2016 - Medical Device Quality Management Systems 3
alonFAI How to define a Risk Based Approach for Supplier Management per ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
B Risk Requirements to meet the explicit Risk Based Approach of ISO 13485:2016 Examples ISO 13485:2016 - Medical Device Quality Management Systems 21
L Risk Management in an IVD, ISO 13485 certified company ISO 14971 - Medical Device Risk Management 2
C ISO 13485 - Documented Requirements for Risk Management ISO 13485:2016 - Medical Device Quality Management Systems 6
somashekar What are the ISO 13485 documented requirements for Risk Management? ISO 13485:2016 - Medical Device Quality Management Systems 13
C Section 7.1 of ISO 13485 - Risk Management throughout Product Realization ISO 13485:2016 - Medical Device Quality Management Systems 7
A How to Rate a Risk Acceptability and on What Basis is it Measured? ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
A ISO 13485 Risk Analysis Requirements for Wound Ointments ISO 13485:2016 - Medical Device Quality Management Systems 13
M Risk management, ISO 13485 and ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 10
M Implementing Risk Management for Contract Manufacturers - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 12
A ISO 13485 Risk Analysis - Class II Medical Device Engineering Changes ISO 13485:2016 - Medical Device Quality Management Systems 9
K What is 'output of risk management' in ISO 13485, Cl 7.3.2(e).? ISO 13485:2016 - Medical Device Quality Management Systems 7
T Risk Management Procedure Mandatory in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 21
W ISO 13485 Risk Management in Simple Terms ISO 13485:2016 - Medical Device Quality Management Systems 22
V Planning of Product Realization - Risk Management - ISO 13485 Clause 7.1 ISO 13485:2016 - Medical Device Quality Management Systems 6
M ISO 13485 training - Understanding of intent and implementation of risk management Training - Internal, External, Online and Distance Learning 1
M ISO 13485 - Risk Assessment for medical device job shop ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO 13485 & ISO 14971 - Requirements for risk management ISO 14971 - Medical Device Risk Management 6
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1

Similar threads

Top Bottom