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
Oct 21, 2024
You know it’s coming, but you don’t know when. Under the EU’s Medical Device Regulation (MDR) part of the auditing cycle for your medical device includes an unannounced visit once every 5 years from your Notified Body. The visit may be inevitable, but that doesn’t mean it’s straightforward.
The good news is that the unannounced visit is very similar to the scheduled visits you’ve already received. And, thanks to our internal expertise (and first-hand experience!), we know there are actions you can take to ensure it goes as smoothly as possible. To help you prepare more effectively, we’ve compiled a list of common questions and answers.
Oct 7, 2024
When you’re bringing a medical device to the EU market or any other country that’s adopted the EU’s Medical Device Regulation (MDR), there are two important things to factor into your compliance journey: time and cost. It can take months, or even years, to bring a medical device to market in the EU. And getting the correct certification isn’t cheap.
To get it there – and keep your product on the market – you need certification, and that requires a long-term relationship with an accredited Notified Body. As we uncover in this article, certification takes time and money, but there are actions you can take to speed up the process and keep a lid on the costs.
Aug 26, 2024
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.
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.