Managing Electronic Instructions for Use (eIFU) systems in line with regulations can be burdensome for manufacturers of medical device and IVD companies. Enter IFUcare, a company leveraging years of experience to provide complete eIFU services to medical device industry customers alongside its regulatory consulting business.
Here, IFUcare’s president and principal consultant, Dirk Stynen, explains how the company has become a market leader in the area of eIFU, and provides insights into how it continues to grow and excel.
How did IFUcare get started in eIFU?
I started in the in-vitro diagnostics (IVD) industry in 1986, beginning in R&D and moving onto quality assurance and regulatory affairs. IFUcare was founded in 2000, building on this experience and with the purpose of assisting companies with dealing with European regulations. The company’s focus was on IVD because that’s my background.
We got into eIFU in 2008, following new guidelines from the European Commission which allowed paper IFU to be replaced by electronically distributed versions. As we worked in the field with customers on how to deal with the requirements of these guidelines, we quickly discovered that it was more difficult than one might think. I realised that we could invest and turn this into a service that would be useful for many customers: a win-win situation for IFUcare and the manufacturers.
The eIFU service fits into my philosophy that, as a company, we try to help customers find solutions to meet regulatory requirements and to make their lives easier. Since then, we have been a kind of hybrid company, offering the eIFU service as well as our incumbent consulting service.
What do you offer your customers?
In consulting, we focus on our IVD customers. We review and compile technical documentation from manufacturers, and we also arrange clinical performance studies for IVDs. We deliberately focus on IVD because our entire team comes from that background – we have not only the regulatory expertise but also the technical competence and field experience. We’ve stayed in this area because our expertise on the regulatory side differentiates us.
There is some overlap between our consulting customers and eIFU customers, but only around 30 to 40%. Many customers in the IVD market use both services, but in addition to that, roughly 50% of our customers for eIFU services are medical device companies, and almost all of them are in the ‘implants’ space.
We are a one-stop shop for all aspects of eIFU management, providing the website, back-up system, free-of-charge paper requests handling, validation and support. We have more than a hundred customers and use our experience and feedback to make continuous improvements. As a result, we are a market leader in eIFU.
What sets IFUcare apart from its competitors?
In regulatory consulting, what differentiates us is our expertise in IVD. The team is highly experienced and has a varied technical background, including 12 PhDs. For every technology that is used in clinical laboratories, we have people with inside knowledge.
When it comes to eIFU, we were by far the first in the market to offer this as a service – we are a pioneer in this area. Coming from a background in quality and regulatory affairs, we were conscious that our service had to meet all the regulatory requirements itself, as well as ensuring that our customers remain compliant. It’s not easy to develop this kind of platform and make sure that it is compliant. As our system is fully compliant and has been approved by many notified bodies before, this facilitates the process for our customers drastically. We can demonstrate that we have done all the validation work, which is critical in the medical device environment, and our validated website provides ready-to-go validation records to customers. This means that it is easy for customers to develop a workable solution for e-documents using our service without having to prove to a notified body that regulations are met at each individual step.
IFUcare will have to be registered as a critical supplier to be able to offer the eIFU solution to the manufacturer. Thanks to our ISO 13485 and ISO 27001 certification, we have sufficient evidence that we are a reliable supplier in terms of managing our quality system, as well as one capable of dealing with information in a secure way.
How do you define your company values?
Our company values are about being ethical and remaining compliant. We want to be compliant ourselves as well as helping our customers with their compliance issues. It’s about being honest and treating our customers seriously.
Within the company I am very lucky to have a great group of people with a very positive, customer-oriented working attitude. As a company, IFUcare will continue to consolidate our strength and lead the market, both in IVD consulting and eIFU.