Qualification of Distributors such as McMaster-Carr and Digikey to Medical Device Companies

racglobal

Involved In Discussions
#1
For a distributor like McMaster-Carr, is this considered a low-risk supplier? How can a company qualify distributors? Is there anyone available to answer questionnaires and send us quality agreements? Some distributors we deal with are McMaster-Carr and Digikey, etc. Any insight would be appreciated.

Thanks!
 
Elsmar Forum Sponsor

Jean_B

Trusted Information Resource
#2
How? by assessment against criteria.
Which criteria? the ones you impose due to company requirements or regulatory obligations.
Skipping company requirements, what regulatory obligations? In the medtech space these are often dealing with traceability, storage and shipment requirements, complaint handling (perhaps including adverse event reporting), and aiding in distribution (and on occassion activities of) of field safety notices/corrective actions. This at least in part by establishing and maintaining a system that generates and retains those records in an appropriate format for swift action.
How do i ensure these are kept? Distribution and/or regulatory agent agreements as appropriate.
How do I deal with the big distributors? Talk to their purchasing representatives or other B2B staff, be clear on what should be their duty as distributor, and what duties belong to a regulatory representative in certain regions (and whether they or another party will fullfil those). Even though they are big, they too must perform their duties according to the regulations, and might even have better ideas on it than you due to the multitude of (their) suppliers they deal with.

Tip: your questionaire is but one method, and might not be the optimal one depending on the power relations between your parties.
 

outdoorsNW

Involved In Discussions
#3
What are the distributors supplying you and what is the risk associated with those products. Who supplies a part is only a small part of the overall risk. Authorized distributors are normally lower risk

Digikey is an electronics component supplier, so I suspect the parts they supply end up in the final product your company sells, and therefore are may no be a low risk supplier.

While I have not personally had any interaction with Digikey, others at my company do. My company does have our electronics distributors complete our supplier survey. Our survey is relatively short and focuses on updating key contacts, verifying that certifications are still current (typically expiration dates, cert numbers, and similar), and making the supplier acknowledge our key requirements.

I have been in a couple of meetings with Digikey's competitors. How you purchase from a distributor may matter. If you establish a commercial account and are assigned a customer service rep., that person can often handle quality agreements, surveys, etc. You may also get better pricing. If you just order from the website, you may not get the same level of service unless you use a commercial account login.

McMaster-Carr sells a wide variety of products. Depending on what you buy and how the products are used, your purchases may be low risk or higher risk. Adhesives and mechanical hardware (screws etc.) are two things McMaster-Carr sells that you might incorporate into your final product, and need to manage the risk accordingly. On the other hand, a ladder likely has no impact on product quality.
 

QE1993

Involved In Discussions
#4
You have to define all of this yourself. The standard says the level of control should be proportionate to the risk associated with the medical device. We can not define that for you or your company. It is possible purchases from McMaster-Carr could be "high risk" for some companies and "low risk" for others, depending on how YOU define high and low risk.

A company can qualify suppliers any way they want, as long as a risk assessment is done to rationalize the type of qualification.

Based off your questions, it kind of sounds like you're putting the wagon in front of the horse here. You really need to have a good understanding of your own purchased processes/goods and how they impact the product you're making. Again, we can not provide this insight to you.

The way other companies qualify McMaster- Carr may not be appropriate for your company. I would suggest sitting down with your team, looking at all your outsourced processes and purchases and determine how they impact/what risk they have on the medical device you're making. You might find during your risk assessments that the items you get from distributors have a low risk factor and you might have a less involved qualification process (no questionnaires/audits/certs/etc required).
 
Thread starter Similar threads Forum Replies Date
Q Are IVD Distributors subject to "Qualification" under our Quality System? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 7
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Reliability Analysis - Predictions, Testing and Standards 0
Y Examples of TRB Reports for MIL-PRF-31032 Qualification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 3
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
T Qualification testing of Lead acid batteries Reliability Analysis - Predictions, Testing and Standards 0
Z Qualification of AzureDevOps in Gxp Qualification and Validation (including 21 CFR Part 11) 12
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 3
B VDA 6.3 Qualification as Process Auditor training course and exam VDA Standards - Germany's Automotive Standards 0
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
H How to prepare Performance Qualification (PQ) for autoclave General Measurement Device and Calibration Topics 2
D ISO 13485 - Equipment validation , qualification Qualification and Validation (including 21 CFR Part 11) 6
DuncanGibbons Qualification vs Certification in an Aerospace context AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
Z Operational Qualification for Injection Molding Supplier Quality Assurance and other Supplier Issues 6
S AIAG CQI Auditor Qualification and 3rd Party Certification Requirements General Auditing Discussions 2
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
xcanals_tecno-med.es Qualification of sterilization indicators as medical devices with the EU MDR 2017/745 EU Medical Device Regulations 7
Z Training Qualification Matrix for ISO 9001:2015 Audit General Auditing Discussions 8
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
J Qualification of a Software as a Medical Device (SaMD) guidance under MDR EU Medical Device Regulations 9
I Compressed air system qualification and 1 micron particle analysis Other Medical Device Regulations World-Wide 0
S Medical Device Supplier Component Qualification Service Industry Specific Topics 0
O Clean room performance qualification (pq) - How many times can I do each test? Manufacturing and Related Processes 8
K Is Mold qualification / process validation always required? Manufacturing and Related Processes 7
Rameshwar25 IATF ADP - How to proceed for new auditor qualification IATF 16949 - Automotive Quality Systems Standard 17
S Do suppliers of prototyping components need to undergo supplier qualification? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Qualification of weights used for curing epoxy Manufacturing and Related Processes 3
M Qualification of Freezer with IQ and PQ but no OQ Qualification and Validation (including 21 CFR Part 11) 2
S Supplier Qualification - How do we determine which suppliers to qualify? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Installation Qualification (IQ) and Operational Qualification (OQ) for Laser Marking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 CE Marking (Conformité Européene) / CB Scheme 3
J Simple supplier evaluation qualification process form that includes Risk Assessment Document Control Systems, Procedures, Forms and Templates 2
D What should an ISO 14644 Clean Room PQ (Performance Qualification) look like? Manufacturing and Related Processes 3
P Qualification of a Temperature Controlled Unit have to be empty? Qualification and Validation (including 21 CFR Part 11) 5
R Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 Other Medical Device and Orthopedic Related Topics 1
O AS9100 AQMS AEA Qualification Audits 4 Full QMS AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
C MSA for Non Manufacturing - Design Validation, Characterization and Qualification Lab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
L Heated Sealed Packages - Sample Size for OQ (Operational Qualification) and PQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
Z Is PPAP Re-qualification needed in case of not quoted dimension change? APQP and PPAP 4
S Qualification Builds & Process Changes (AS9102 - First Article Inspection) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
A Tracking Calibration and Qualification in an MS Excel Spreadsheet Calibration and Metrology Software and Hardware 6
P FDA has just released the forms for "Small Business Qualification and Certification" Other US Medical Device Regulations 6
P Vision Measurement System - Software Program Qualification Qualification and Validation (including 21 CFR Part 11) 6
C Process Qualification Sample size Document Control Systems, Procedures, Forms and Templates 6
P CMM Equipment Validation and Qualification Approach ISO 13485:2016 - Medical Device Quality Management Systems 11
Similar threads


















































Top Bottom