Responding to customers upon receipt of an alleged medical device deficiency

M

merlinpa

#1
How do you acknowledge receipt of a customer report of an alleged deficiency of a medical device? Is it any different then if they report problems with your delivery of an order?
 
Elsmar Forum Sponsor
P

Phil Fields

#2
Re: Responding to customers upon receipt of an alleged deficiency

Without more information it is difficult to respond, I assume that you work for a medical device manufacturer. 21 CFR Part 820 details Customer Complaints in section 820.198.

Phil
 

Doug Tropf

Quite Involved in Discussions
#3
How do you acknowledge receipt of a customer report of an alleged deficiency of a medical device? Is it any different then if they report problems with your delivery of an order?
In addition to the requirements of 21 CFR 820.198, you need to determine if the alleged deficiency warrants a report to the FDA under Part 803.
 
M

merlinpa

#4
The requirements of 21 CFR and 13485 are apparent and recognized.

I was not specific enough in my request for information. What I am looking for examples of letters/communication that the manufacturer sends back to the complaintant to acknowledge initial receipt of an alleged deficiency.
 
M

MIREGMGR

#5
How do you acknowledge receipt of a customer report of an alleged deficiency of a medical device?
We start with a same-day phone call, either from the President of the company (who is also the Sales Manager at present), or the Sales/Marketing Coordinator if the President is out of the office. Other people (the salesman, the Customer Service Manager, me as Regulatory Manager, the Quality Manager) could sit in on the call, depending on the issues involved.

Written follow-up is customized to the circumstances. i.e. nature of the reported problem, the particular customer, their type (OEM or distributor), their location and thus regulatory system, etc.
 
A

Action Mike

#6
Here is a basic template example for the initial customer response (file attached). It is typically a starting point, so the final format is usually more detailed. Since it is a template, the Concern Owner may personalize it for the customer or for the severity of the problem.

The same template is utilized for generating a hard copy letter, email message, or fax.

Pre-formatting templates accomplishes two important goals:

1. Deliver a consistent customer or consumer reply each time no matter who is generating the response.

2. Facilitates a faster, easier initial response.
 

Attachments

Ajit Basrur

Staff member
Admin
#7
In most cases, the Quality Manager acknolwedges the complaint by responding through email and informs the Customer that a detailed report would be sent by xxxxx (date).
 
Thread starter Similar threads Forum Replies Date
N Is there a standard length of time to track down non-responding customers w recalls? Misc. Quality Assurance and Business Systems Related Topics 2
J Supplier not responding to PPAP request APQP and PPAP 5
N Responding to NADCAP nonconformance - Control of External Documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Technical Documentation Review: Responding to a Nonconformity ISO 13485:2016 - Medical Device Quality Management Systems 14
K Suppliers not responding to Supplier Corrective Action Requests (SCAR) Supplier Quality Assurance and other Supplier Issues 12
W Responding to an FDA FOIA Request US Food and Drug Administration (FDA) 5
R Responding to a Customer Identified Nonconformance caused by Human Error Nonconformance and Corrective Action 22
M Operator Mistakes (Errors) and responding to CAR (Corrective Action Requests) Nonconformance and Corrective Action 20
AnaMariaVR2 Strategic Priorities: Responding to the Public Health Challenges of the 21st Century US Food and Drug Administration (FDA) 0
Q Not responding all the NCR?s Nonconformance and Corrective Action 10
F Responding to Audit Findings - Procedures not being followed to the letter ISO 13485:2016 - Medical Device Quality Management Systems 28
J Time Frame for Responding to a Major Nonconformance - Registrar Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Responding to ISO9001 Audit NCR?s/Observations - ?Top Management? ? Clause 5.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
M Workmanship Related Failures - Responding to a customer CAR Nonconformance and Corrective Action 12
ScottK Responding to calls for references, how do you handle it? Career and Occupation Discussions 5
B Responding to ISO9001 or TS16949 Audit NCR?s/Observations. Nonconformance and Corrective Action 5
D Overwhelmed, next audit around the corner - Responding to Nonconformances Identified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
M Responding to external communciation - In particular 4.4.3 b) - Dinged Miscellaneous Environmental Standards and EMS Related Discussions 6
S The Unreasonable Customer - Responding to 3 or more Customer Concerns a Day Customer and Company Specific Requirements 26
B Request: Suggestions / Tips for Responding to CAR for Late Deliveries Nonconformance and Corrective Action 14
I Corrective Action Time Line When Responding to a Major from a Registrar IATF 16949 - Automotive Quality Systems Standard 8
B Cybersecurity Maturity Model Certification for military customers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
P ISO 9001 certification with zero customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J Which OEM or customers are now requiring the new AIAG/VDA FMEA format? FMEA and Control Plans 2
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
NDesouza When Customers Make Changes to Orders Contract Review Process 24
T Was Just told we could ONLY buy material for AS9100 customers if the DISTRIBUTION house is AS9100 / AS9120 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Customer and Company Specific Requirements for notification of Customers of a change in Management or Key Personnel Customer and Company Specific Requirements 3
S Returned product due to Customers fault, is it a Non-Conformance? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Sidney Vianna Interesting Discussion ISO 9001 audits from the perspective of registrants' customers - an interesting paper Registrars and Notified Bodies 0
S How to collect complaint data from customers Customer Complaints 24
A CE Mark PPE Category III for our customers residing in the EU CE Marking (Conformité Européene) / CB Scheme 1
Ed Panek Requirement to track and trend positive feedback from customers ISO 13485:2016 - Medical Device Quality Management Systems 12
R Medical Device (IVD) - Selling RUO to Customers EU Medical Device Regulations 2
T Restricting scope of AS9100 certification to a couple of customers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
C What are rules to notify customers if IATF cert is put on hold? IATF 16949 - Automotive Quality Systems Standard 2
R Concessions - ISO 13485:2016 requires concession approval from customers Nonconformance and Corrective Action 2
G AIAG FMEA - Major customers of the FMEA process FMEA and Control Plans 3
C Record retention for defunct customers? ISO 13485:2016 - Medical Device Quality Management Systems 11
M Can a foreign manufacturer sell directly to US customers? Other US Medical Device Regulations 4
D AS9100D 7.3 Awareness of customers quality policies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
A Special Procedures for Non Aerospace Customers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R AS9100 FAI - First Article Inspection to a prior Customers PO AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
B TS16949 Section 8.2.2.3 Product Audit - Requirements for various Customers IATF 16949 - Automotive Quality Systems Standard 10
Crimpshrine13 IATF 16949 Audits to include Processes and Products from Non Subscribing Customers IATF 16949 - Automotive Quality Systems Standard 20
N Do you make exceptions to your process for customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D TS16949 requirements for for Directed Buy Customers IATF 16949 - Automotive Quality Systems Standard 5
M Document Control Management - External documents flowed down from customers Document Control Systems, Procedures, Forms and Templates 2

Similar threads

Top Bottom