PEERCODE Regulatory Consultancy

We offer clients quality and regulatory services, auditing, training and assist in bringing medical devices to market

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Services

We offer the following services to support your company with quality-, law- and regulatory-based challenges in the field of medical devices.

Peercode’s CE certified software products

Atris logo

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 logo

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 logo

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-air

Customers

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

Jul 1, 2024

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.

The Medical Device Technical File – A Roadmap For Compliance
May 29, 2024

Any medical device destined for the EU market needs a technical file. And if you’ve been following our blog, you know that a vast amount of documentation is needed to get a product certified under the Medical Device Regulation (MDR). That documentation must also be accurate, and structured in the right way.

Whether you’re a newcomer to the medical device market or part of a seasoned medtech team releasing a new type of product, knowing what you need to include, and how to get started with your technical file isn’t easy. That’s why you need a roadmap for compliance.      

Regulatory Compliance In Medtech: The Cost Of Getting It Wrong
May 2, 2024

Get regulatory compliance right for your medical device product, and you benefit from a smoother path to certification, a speedier time to market, and a strong competitive advantage. But get it wrong, and you’re staring at a mountain of costs in terms of time, money, and human resources. 

At best, getting it wrong can delay a product on its journey to market. At worst, it could lead to product recall or to not entering or removal from the market, not to mention lasting damage to your company's brand’s reputation. Either way, the cost of quality is lower than the cost of noncompliance. That’s why it pays to get compliance right first time. 

Knowledge center

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.

Our Team

Peercode Regulatory Consultancy is part of Peercode. Visit the Peercode website to get an overview of all our services. The Peercode Regulatory Consultancy team introduces itself here:

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.