If you are planning to (or already) outsource the engineering of a medical device project, the setup is important to ensure the success of the project. Unfortunately, experience has taught us, that a lot of medical device manufacturers or their outsourcing partners do not have sufficient quality processes in place to guarantee a project success. In this article we outline how IMT, as an engineering service provider, supports our customers in this regard and have allowed us to complete over 500 successful projects for over 120 customers in the last 30 years.
Obligation to monitor the engineering service providers
ISO 13485, the European MDR and a lot of other national regulations require, that the legal manufacturer need to monitor the engineering service provider and retain responsibility of conformity. The clearest way to write it, can be found in ISO 13485:2016, where it is written as following:
4.1.5 When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes. The organization shall retain responsibility of conformity to this International Standard and to customer and applicable regulatory requirements for outsourced processes. The controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements in accordance with 7.4. The controls shall include written quality agreements.
Quality Assurance Contract (QAC)
Prior to the start of the project, we sign the Quality Assurance Contract with our customer. QAC usually is drawn up on the template of our customer and contains the salient points of the engineering project. It does regulate for example the auditing right of the customer, its notified body or competent authority, the retaining period required for project documentation and so on.
If a customer (for example a start-up company) does not have a QAC template, we use IMT template which contains the key points important for European legal manufacturers.
Quality Assurance Plan (QAP)
To outline the exact responsibilities between IMT and customer during specific project, we draw up the project’s Quality Assurance Plan. Below I will outline the key elements of QAP template, that IMT is using.
One of the responsibilities of the legal manufacturer is to ensure the competences of the project team members. Therefore the Quality Assurance Plan describes specific skills required per role in the project.
Another requirement for the legal manufacturer is to ensure that state of the art development tools are used and software is validated. This is covered in another section of our QAP template.
The last section of QAP describes the deliverables and responsibilities list. The deliverables list follows IMT System Engineering SOPs and gets occasionally enhanced by additional deliverables per specific customer process requirements. For each deliverable it is defined who is the author (IMT or customer), on which template it is created, when it needs to be reviewed by customer and signed-off.
These are only few of the QAP sections, but they show the importance to clearly define the project interfaces between a legal manufacturer and an engineering service provider for the project to be successful.
In summary, it is crucial for medical device manufacturer and engineering service provider to reach a thorough understanding between parties and an agreement on QAP before the project start.
With over 30 years of experience in the development of medical devices, IMT’s engineering experts have successfully completed over 500 projects. Our personal service, regulatory affairs expertise, lean structures and ability to adapt to our customers needs, make us a preferred development partner for many top companies in medical technology and industrial applications.
Do you need support in developing your medical device and bringing it to the market on time? Would you like to create a proper QAP with your service provider?
Please get in touch with me – I will be happy to support your project.
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