PEERCODE Regulatory Consultancy
We offer clients quality and regulatory services, auditing, training and assist in bringing medical devices to market
Services
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 CE certified software products
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-airCustomers
Our 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.
This is what our customers say
Blog
Mar 10, 2025
Before the introduction of the Medical Device Regulation (MDR), medical devices in the EU were certified under the Medical Device Directive (MDD). Many of these so-called ‘legacy devices’ still remain on the market under valid MDD certificates.
However, as the EU slowly shifts to the MDR, medical device companies must transition their products to the new regulations. The MDR is more stringent than its predecessor, so it’s easy to see it as an increased and unwelcome burden.
That’s why we’re dedicated to making the transition easier, helping you turn mandatory regulatory transition into a valuable business opportunity. Read on to learn more.
Feb 17, 2025
Regulations around medical devices rarely stand still. A number of factors, most notably the EU’s landmark AI Act, mean 2025 is shaping up to be a milestone year in the field of regulatory compliance for medtech products.
Medtech companies typically tackle the compliance challenge in two ways. First, by staying on track to meet upcoming regulatory deadlines. Second, by being ready to respond and adapt to regulatory changes as they happen. To help get your compliance efforts off to a flying start, here’s a list of what’s hot for 2025 and beyond.
Jan 6, 2025
Preparing an effective technical dossier for your medical device products is rarely straightforward. One of the major considerations is how you define your product. Is it one product, perhaps configurable, or is your product part of a family? In fact, this crucial step can be the difference between a manageable workload and an overwhelming pile of documents and separate dossiers.
For medical device manufacturers already established in the EU market, transitioning to the MDR is an additional compliance burden. This is especially true when you have a portfolio of products to re-certify under the latest regulations. That’s where careful planning, and a more strategic approach to structuring your products, can help ease the burden.
Knowledge center
Position Paper Digital Therapeutics
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.
About Peercode Regulatory Consultancy
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.
About Peercode
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.
History Peercode
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:
- ‘peer’ (Dutch for ‘pear’) refers literally to the pear orchards in the Geldermalsen region (Dutch municipality in Gelderland, Holland),
- ‘code’ because we encrypt the needs of our clients and our own ideas and translate them into inspiring applications.
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.