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?

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

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.

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.

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.

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.

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).