We offer the following services to support your company with quality-, law- and regulatory-based challenges in the field of medical devices and in-vitro diagnostic devices.
Peercode’s Atris is a telemonitoring system that can be used to gain further insight into the (movement) patterns of (revalidating) patients for both the patients and physicians.
More about Atris
IMID monitor is a software application that supports patients with rheumatoid arthritis and inflammatory diseases in the clinical environment/setting.
More about IMID-monitor
MASK-air is an application created for people with allergies and asthma. It helps patients keep track of their symptoms and medication use and sends a notification when certain limits are exceeded.
More about MASK-airOur ambition is to assist customers with bringing and keeping innovative medical devices to market. Our clients vary from startups and small businesses to large mutli-nationals.
Developed and drafted at the same time as the Medical Device Regulation (MDR), the In Vitro Diagnostic Regulation (IVDR) is a significant legislative framework that governs the safety and performance of in vitro diagnostic medical devices (IVDs) in the EU. IVDs are used to perform tests and experiments on biological samples (like blood, tissue, or cells) outside a living body, typically in a lab.
IVDs help in diagnosing diseases, monitoring health conditions, or studying biological processes. For example, a blood glucose test kit that measures sugar levels in a blood sample taken from the body is an IVD. In recent times, most of the world’s population has had first-hand experience with IVDs in the form of COVID-19 test kits. For manufacturers of these IVDs, understanding and complying with the IVDR is essential.
Since coming into effect in 2021, there have been a number of major amendments to the EU’s Medical Device Regulation (MDR). Adapting to these amendments puts additional pressure on medical device manufacturers, increasing the burden of compliance, putting a strain on internal resources, and causing something of a regulatory headache.
But it doesn’t have to be that way. In this article, we explore how to handle MDR amendments – both today and tomorrow – by bringing in the right external experts. At the same time, we’ll look ahead at anticipated future changes that could impact your medical device company.
Even a cursory glance at the EU’s Medical Device Regulation (MDR) – over 170 pages, more than 100 articles, plus 17 annexes – tells you one thing: there are no quick-fixes when it comes to regulatory compliance for medical devices.
To avoid the hassle, delays, and ongoing back and forth with a Notified Body, many medical device manufacturers seek external expertise on regulatory compliance. That’s because getting the Quality Systems Requirements (QSR) and the product documentation right first time enables them to bring their medical device to market, faster and more easily.
This is why many medical device companies turn to consultants who possess both regulatory expertise and the ability to take a personalized approach to compliance. In other words, they seek consulting excellence that fits their organization and product.
Digital Therapeutics (DTx) are evidence-based therapeutic interventions that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. There lie many opportunities in the integration of DTx in the current health care system. There are several ways in which the DTx can generate value and the working method differs largely between products. As the number of patients with chronic illnesses grow over time and the future global digital therapeutics market size is predicted to continue to grow, the need for pharmaceutical companies to shift their focus towards DTx increases.
The new Medical Device Regulation (MDR) ensures that the emphasis is on patient safety, but also entails a lot of additional requirements. We have experienced ourselves from Peercode what this process entails for software products. Based on our own experience in marketing medical devices, we like to support other companies in this process. That is why we have a Peercode Regulatory Consultancy branch within Peercode, where we combine our personal experience and the experience of Peercode to help our customers. We are a small company and like a pragmatic approach. Thinking from the product and the existing processes and translating this into good documentation at both process and product level. We are happy to offer support to allow a system to grow, after which the customer is aware of all regulations and quality requirements and can put an innovative product on the market.
Innovation is in our code. Since 1999, we have developed software solutions for clients such as: KLM, Robeco, Police, Fire Brigade, Arbo Unie, Erasmus MC, Pfizer, Meda Pharmaceuticals, Ministry of Justice and UMC Groningen.
In the area of health and movement we have 3 products, software as medical device, on the market under the MDR.
Peercode consists of an experienced group of professionals in the area of software engineering, web design, user experience design, CE registration, (cognitive) ergonomics and app development.
We help you convert your knowledge and ideas in the area or lifestyle and health into inspiring websites and (mobile) applications. By means of a sophisticated design, storytelling and scientific research, we translate your creative ideas into effective applications.
Peercode was founded in 1999 and started under the name in2sports. On 1 November 2012, this name was changed to Peercode. The reason for this name change was due to the fact that, in addition to the domain of sport and health promotion, more and more clients also have and implement projects in the medical domain. The name ‘in2sports’ raised questions about that and also had confusing associations.
The name Peercode is a combination of the words “Peer” and “Code”: “code” referring to software development, which is an important part of the company, and “peer” which is also strongly associated with the web/computers (peer-to-peer, peer review, etc.).
But also:
Peercode currently has a balanced team of experienced professionals from various fields, such as management, marketing and sales, software architecture, web design, (cognitive) ergonomics and sport and health. Peercode has further developed over the past years and is now also active on the international market.
