Here is why you can rely on moveUP: our certification and clinical validation story

When we say that the moveUP system is safe, secure, efficient, and high-quality, we make sure to have proof for it.  

Since getting CE-marking in 2017 and going commercial, we have continued doing clinical research, and audits. Our processes, protocols, and systems are in line with the following certifications and guidelines:

• ISO 13485
• ISO 27001
• IEC 62304
• Recognized protocol guidelines , such as NICE
• FDA guidelines
• HIPAA compliant

Here is how we got internationally-recognized certificates and validated our product through multiple clinical studies.

Right from the beginning, clinical validation was moveUP's top priority. When we just started, we focused on closely following the work and needs of patients, doctors, physical therapists, caregivers, and other experts. Back then, we firmly decided to create a secure and efficient system that is valid according to the then current standards.

We have been rigorous when it comes to certifications and validations. These certifications are external proof of our work. We also see them as a quality guarantee to the hospitals, clinics, and professionals that we work with. Our partners know that they can rely on us and that we are always keeping up-to-date with the newest changes, standards, and regulations.

Here is a timeline of our certifications and clinical studies:

• 2017: mHealth study started; October 2017: we got CE marking  
• 2018: mHealth study finished  
• 2019: we got the ISO 13485 certification  
• 2020: Surveillance audit for ISO 13485; we gained the ISO 27001 certification  
• 2021: Surveillance audit for ISO 13485 and ISO 27001 certification
• 2021: Start of a multi center randomized controlled trial in 15 hospitals to get reimbursement in Belgium https://clinicaltrials.gov/ct2/show/NCT04628468?term=moveUP&draw=2
• 2022: Stage 1 of MDR audit
• 2022: Retrospective study of implementation of shorter length of stay with the help of the moveUP app
• 2023: Prospective cohort study on digital rehabilitation after knee arthroplasty
• 2023: Start of a randomized controlled trial on digital therapy after shoulder arthroplasty
• Upcoming: Recertification audit for ISO 13485; Surveillance audit for ISO 27001; Stage 2 of MDR audit

A study that earned us the CE-marking

We invested considerable time in the initial market research at the beginning. As a team with a medical background, we saw the healthcare world changing. After all, the needs of patients are changing, and we wondered how we could help healthcare adapt to that. In particular, we noticed the need to:

• Reduce variability of care and optimize outcomes for patients  

• Reduce the incidence of chronic pain  

• Reduce readmission rates and number of unplanned consultations  

During our literature review in 2017-2018, we found studies that show how home-based rehabilitation is equally effective as center-based rehabilitation. Moreover, rehabilitation at home may bring additional benefits, such as lower costs for patients. That confirmed that a system like moveUP could increase the quality of care and patient experience after a knee or hip arthroplasty.

We felt it was time to put this into practice.

In 2017, we started our first study, the mHealth study, which turned into the validation of our proof of concept. The study was funded by the Belgian government and included 200 total knee and total hip arthroplasty patients. The study participants confirmed the safety and effectiveness of the moveUP app.

Thanks to the positive results of this study, we received a CE marking in October 2017. CE marking means that our product meets the European Union's high safety, health, and environmental protection requirements. Furthermore, it meant that we were ready to put our product on the market. Finally, after two years of intense research, development, and preparation, we officially had a commercial product to offer.

Yet, in many ways, our story has only begun.

Getting the ISO certifications

As a medical device manufacturer, fulfilling our users requirements, regular clinical evaluation and validation is our obligation and ambition. Thus, we have created a quality management system that complies with the international standard IEC 62304 for the medical device software. In addition to this, we have a protocol in line with the NICE guideline for hip and knee postoperative rehabilitation.  

But we go further than this.

In 2019, we earned the ISO 13485 certificate, meaning that moveUP has proven to have all necessary processes and a quality management system in place to guarantee patient safety and effectiveness. Since then, we have had regular surveillance audits to keep up to date with ISO standards.

Because we also care about cybersecurity and the safe management of the data we collect and store, we obtained ISO 27001. This certificate is proof of having processes to manage cyber security risks, which complies with the field's high international standards.

The journey of getting these certifications and the ongoing audits they require encourage us to continue improving the quality and safety of moveUP. In line with that, we focused on doing more research, especially in the past couple of years.

Ongoing evaluation

Our research never really stopped. We carried on with the patient interviews on a yearly basis since the start of the mHealth study. We continued to review and compare the results of the patients who participated in that study, analyzed the problems they reported, and compared our results to the literature. By the end of the mHealth study in 2018, our data confirmed that the quality of care, satisfaction and safety levels are equal as standard of care and that we can extend our solution beyond knee and hip rehabilitation.  

Moreover, we started doing regular experience interviews with healthcare professionals. From 2019 onwards, we have strong, ongoing cooperation with professionals and hospital experts. We talk to and ask for feedback from a diverse and multidisciplinary group of medical professionals. This approach helps us consider different aspects of care and remote rehabilitation.  

In 2020, we did an in-depth investigation on complications and readmission that either patients or physical therapists reported in the moveUP system during that year. After an analysis, we were glad to see that none of them were directly or indirectly due to the use of our app. We repeated the same the following year and came to the same results. The patient's predisposition, surgery impact, or unfortunate accidents like a fall have most likely contributed to the reported complications. We also saw a positive trend for hip patients. The number of patients reporting a severe complication or readmission to the hospital dropped to 0% in those two years.  

In 2021, we also studied the impact a shorter length of stay (LoS) has on complications and hospital readmissions. Considering that many hospitals had to shorten the LoS for their knee and hip surgery due to the pandemic and limited capacity, we saw this as particularly relevant for the future of remote therapy. For this study, we analysed the data of pre-pandemic and pandemic patients who had their surgery between 2018 and 2021. Our data shows that shortening the LoS does not negatively impact the rate of complications, readmissions, or clinical outcomes. That is, in a context where the patients get a proper follow-up and guidance after leaving the hospital. We wrote about this study in our earlier blog post. You can also download the full research paper for free here.

Current and future plans

The results and feedback we got over the years show that the patients feel safe and satisfied while using the moveUP app. We also have excellent ongoing communication with the medical professionals who have experienced improvements in their work since partnering with us. For example, the team from AZ Mol hospital saw their work with patients becoming more meaningful, valuable, and reliable. There is a video about their case here.

Our recently concluded clinical study, under the diligent supervision of an independent entity, is now in the results assessment phase. The initial findings have been exceptionally promising, echoing the existing literature. Our research endeavored to examine the impact of a mobile application on knee and hip rehabilitation, along with assessing its influence on quality of life, in comparison to standard care. The study encompassed over 1,000 patients across Belgium. Despite a projected completion in May 2022, pandemic-induced delays pushed our timeline further. Nevertheless, we anticipate unveiling the complete findings by the year's end. For a comprehensive overview of the study, please click here.

Because of the third-party certificates and clinical study records, people who use our app or work with our system can count on getting a secure and high-quality service and product. The patients do not have to worry about their data or privacy. We are using physical, organizational, technological, administrative measures to protect any personal and health data against unauthorised use and leakages. Their medical information is safe with us, and they can focus on their recovery. Similarly, our medical partners can rest assured that their patient's data is protected.

Working with us means that you guarantee that the data you collect and store is secure. Additionally, you are offering a valid, recognized, high-quality, and safe rehabilitation tool. It means knowing that your practice complies with the latest standards.

Interested to know more about our certifications and validation processes? Our team will be happy to answer any questions you may have.

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