Approved Vendor (Supplier) List Issues - Class II medical device maker

D

DonkeyKong

#1
Does anyone have a feeling on Approved Vendor issues with the new QSR FDA regs?....I was wondering if it fell along the same lines as the ISO 2000 standard where you keep documents concerning "vendor approval/audit" and a "approved vendor list". Are the FDA requirements much, much more stringent?....I am in a battle at work right now trying to simplify our system.....

We are a class II medical device maker of medical device items..

Any help would be much appreciated.

Thanks,
DK:bigwave:
 
Elsmar Forum Sponsor
R

RosieA

#2
I am no longer in the Medical Devices world, but when I was three years ago, there were no differences between how I dealt with the approved supplier requirement as an ISO issue and as a CGMP issue. I never had any FDA comments or findings on it either.

Is there something specific (like wording) triggering your question?
 
A

Aaron Lupo

#3
Re: Approved Vendor List Issues

DonkeyKong said:

Does anyone have a feeling on Approved Vendor issues with the new QSR FDA regs?....I was wondering if it fell along the same lines as the ISO 2000 standard where you keep documents concerning "vendor approval/audit" and a "approved vendor list". Are the FDA requirements much, much more stringent?....I am in a battle at work right now trying to simplify our system.....

We are a class II medical device maker of medical device items..

Any help would be much appreciated.

Thanks,
DK:bigwave:
With the new FDA regs?

If you look at 820.50

3) "Establish and maintain records of acceptable suppliers, contractors and consultants."

Now does it say you need an approved suppliers list, no but I think it would make it a heck of a lot easier on the people in the company if you did have a list so they know who they can order from. Just a thought.
 
Thread starter Similar threads Forum Replies Date
Q AS9120 Vendor of ESD Monitoring Equipment needs to be in the Approved Supplier List? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
K Approved Vendor (Supplier) List and Supplier Evaluation Supplier Quality Assurance and other Supplier Issues 16
T AVL (Approved Vendor List) Supplier Listing - ISO 13485 Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
N Acceptance of Supplier to AVL (Approved Vendor List) - How long? Supplier Quality Assurance and other Supplier Issues 9
R Approved Vendor (Supplier) List contain Vendor Evaluation? Supplier Quality Assurance and other Supplier Issues 6
R Approved Vendor (Supplier) if Customer Pays Sub-tier Shipping Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D How can a vendor (supplier) with no third party certification be approved? Supplier Quality Assurance and other Supplier Issues 1
Q Do I have to qualify my approved vendor (supplier) status? Supplier Quality Assurance and other Supplier Issues 2
C Approved supplier/vendor - How do I approve my Registrar? Supplier Quality Assurance and other Supplier Issues 17
P Seeking: Approved Supplier (Vendor) Log Example Supplier Quality Assurance and other Supplier Issues 35
T Our Approved Vendor / Supplier list contains EVERY supplier we currently have Supplier Quality Assurance and other Supplier Issues 15
N Which Suppliers Belong on my AVL (Approved Vendor List)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
K Method to qualify COTS Suppliers into AVL (Approved Vendor List) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M AVL and Non-AVL is that a contradiction - Approved Vendor List Supplier Quality Assurance and other Supplier Issues 7
M Distributors and the Approved Vendor List Other ISO and International Standards and European Regulations 5
S Customer Specific Requirements (CSR) not signed/approved IATF 16949 - Automotive Quality Systems Standard 17
M Requirements for an MDD approved device after 26/05/2021 EU Medical Device Regulations 3
S Shipment of a CE Approved Class III Device to the EU Member States Other US Medical Device Regulations 1
Ajit Basrur Why is ISO 14644-3:2019 not approved by US? Other Medical Device Related Standards 1
I Approved Suppliers ISO/IEC 17025:2017 and used test equipment ISO 17025 related Discussions 6
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
Kuldeep Singh Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
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
D Document review on already approved registrations requested by China's NMPA? China Medical Device Regulations 3
F List of approved API manufacturers or Formulations manufacturers US Food and Drug Administration (FDA) 0
J Change management with CFDA approved devices China Medical Device Regulations 1
J Dr Training Records - Training doctors to use a PMA approved medical device Other US Medical Device Regulations 2
L CQI & IRCA not accepting new applications for ATPs (Approved Training Partner) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 6
D FDA filing guidance to add sterilization step for approved drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
Jane's Should the facility landlord be an approved supplier? Supplier Quality Assurance and other Supplier Issues 12
I Adverse Event Reported during Non-Approved Indication Use EU Medical Device Regulations 4
F Scientific and Research Papers for Foreign Approved Devices Other US Medical Device Regulations 1
P Approved Supplier Register and Calibration Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J FDA approved Medical Devices for PVD and DLC Coatings US Food and Drug Administration (FDA) 2
M ISO 14971:2007 Revision Approved - The Delft ISO TC 210 plenary meeting - Nov 2016 ISO 14971 - Medical Device Risk Management 2
H IVD in US Phase III Clinical Trial - Non-CE Marked and Non-FDA Approved Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
J Why Control Plan Review needs to be Approved by the Customer IATF 16949 - Automotive Quality Systems Standard 1
F China Medical Device Labeling - Not approved for use, is for an exhibition EU Medical Device Regulations 4
S API Q1 Approved Training & Professional Certification Sources Oil and Gas Industry Standards and Regulations 5
gunnyshore Benchmarking: Approved Supplier List for Multiple Sites Supplier Quality Assurance and other Supplier Issues 2
S Why Drugs and generics are Approved while Biologics are Licensed ? US Food and Drug Administration (FDA) 1
L Do HR consultants need to be on Approved Supplier List? Supplier Quality Assurance and other Supplier Issues 5
M Making a change to an approved Medical Device Other US Medical Device Regulations 9
D Is a separate spreadsheet required for the ASL (Approved Supplier List)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Investigational Device Exemption approved 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Do Machine Service Contractors Need to be an Approved Supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Can I ship Demo Units to the UAE if we are not Approved? Other Medical Device and Orthopedic Related Topics 2
J PT/ILC - No Approved Programs within our Scope of Accreditation General Measurement Device and Calibration Topics 2

Similar threads

Top Bottom