How do you ensure the success of your outsourced engineering project?

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 for conformity. The clearest way to write it can be found in ISO 13485:2016, where it is written as follows:

ISO 13485:2016

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 the responsibility of conformity to this International Standard and to the 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.

How does IMT as an engineering service provider support the customers in this regard?

Quality Assurance Contract (QAC)

Prior to the start of the project, we sign a 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 an IMT template which contains the key points important for European legal manufacturers.

Quality Assurance Plan (QAP)

To outline the exact responsibilities between IMT and the customer during a specific project, we draw up the project’s Quality Assurance Plan. Below I will outline the key elements of the QAP template, that IMT is using.

One of the responsibilities of the legal manufacturer is to ensure the competencies 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, and when it needs to be reviewed by the customer and signed off.

These are only a few of the QAP sections, but they show the importance of clearly defining 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.

QAP advantages

• Things do not get lost – QAP prevents the risk that some project deliverables may be dropped due to a misunderstanding between the parties about whose responsibility it is
• Optimized resource usage – QAP allows to use efficiently the competencies on both sides, in case the customer wants to bring his own resources into the project or in case the engineering provider needs to exchange the team members during the project
• Time to market – clearly defined interfaces and deliverables prevent gaps of missing documentation, which leads to quicker turnaround times during technical file reviews by notified bodies or competent authorities. Also, during quality management system audits, our customers can easily show their compliance with regulations and standards by having objective evidence of their control over the supplier.

Why do customers trust IMT

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 customer's 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 Beat Keller, Head of Regulatory Affairs and Quality Management – He will be happy to support your project.