Eckhard Jokisch Hi Richard, one of my clients has outsourced ALL of the ISO-13485 processes except clause 5 (Top management responsibilities) to different parties in a way that even those parties control each other. The top management receives filtered feedback data (based on well defined filtering rules) for their management review processes.
Feel free to contact me for more information.

Hi Richard I have used a company called WIPRO in the past, mainly for complaint intake activities across APAC but they could be capable of a global reach. They worked out of the Phillipines and we used Trackwise for managing complaint data.

Armin Beck Many companies tried that about 10 years ago and what I know it did not work very well Complaints management and mdr reporting is difficult and a company needs internal resources.

Hi Richard , I have seen multiple such initiatives. We can connect to discuss the same

Rakesh

Edwin Bills, ASQ Fellow, RAC Outsourcing of these activities is possible, but remember you cannot outsource the responsibility. You company is responsible for the entire content of the device and the regulatory requirements including complaints and postmarket surveillance. Your supplier controls should include all aspects of selecting and monitoring these suppliers (See GHTF Supplier Control guidance SG3/N17 at http://www.imdrf.org/documents/doc-ghtf-sg3.asp
for more information on supplier controls. This document includes guidance on selecting suppliers as well as all other associated activities. Make sure the selected supplier meets your requirements. Yes you must identify the requirements of those activities you wish to outsource before you select a supplier.

Jose O Cotta At this time it is possible to outsource every function in an organization from anywhere in the world. The key word is well defined filtering rules.
We did this with password control

Jonathan Wacks Do you really, really want to do that?

Richard Alberti Yes I am interested in learning more.

We recently looked at a couple of service providers already supplying other services and one of them was very impressive with a currently running large comolaint handling and regulatory reporting operation in the Philippines. Private message me for more information.

Jean-Jerome Dubus Hi. I've more than 10 years experience with the outsourcing of post market surveillance activities. I suggest the way you re delegating and interacting with your 3rd party supplier is key. For sure right selection to get the one who can support in term of size and territories is the 1st step. Then you could become incredibly proactive and the resources allocation could be adjusted in term of demand I.e. workload but more important technical or specific expertise. Finally to have some people on board who can control operations and experience with 3rd party is the key success factor. See Dr Ebeling & assoc. Gmbh in Hamburg.

Teresa Gorecki Rich-
I looked at this inside J and J. I now work for a consulting firm that provides outsourced services. Do you want to connect?

Sue Soderholm Hospira successfully outsourced the intake process, metric generation and trending. The investigations still were managed by the affected area and final responses sent by then outsourced company unless high level, ie FDA response, and was sent by the internal staff. As stated earlier, internal resources must manage this and are ultimately responsible. Please reach out if more details might assist!!

Ali Fouani Why would you want to do this? What is the GOAL?

David P Norby, PhD, CQE (ASQ) Let me suggest that outsourcing this activity is a big mistake. When this is outsourced, the complaint handling activity becomes little more that a routine "find a way to close this out" activity. It is very unlikely that much will be learned about the product from complaint investigations if third-party group is conducting the activity. There is no incentive for the third party to proceed in any way beyond the exact protocol you provide them for doing investigations. Unfortunately, it is virtually impossible to anticipate all of the different ways that handling or use of your products can lead to complaints. Sometimes your product will fail in ways you did not, and even could not, anticipate. It is your own people, knowing your products and their design, who are in the best position to identify new modes of failure, and consequently new types of opportunities for improvement. (safer, more robust, more reliable, easier to use). A third party needn't care about improvement.

Ruth Grant I am more than competent, available and happy to help

Please give me your email id / contact details. mine is vimal.puthiyadath@kpit.com