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 and in-vitro diagnostic devices.

Peercode’s CE certified software products

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.

logo DSM logo Equipe logo KYomed-INNOV logo pfizer logo ECM-Europe-BV logo Sanofi

This is what our customers say

Blog

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The Peercode Advantage – Regulatory Expertise For Medtech Companies
Apr 4, 2024

Companies entering a medtech market for the first time – or even those transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) – face a mountain of regulatory compliance. Whether you’re two people in a room, or tens of people on an office floor, resources can quickly become thin. The fact is, people in smaller organizations often have to fulfill multiple roles. 

Now add the burden of regulatory compliance into that mix. Who in your organization has the time, expertise, and strategic know-how to get it done? There’s no quick fix, but wouldn’t it be great to lean on a regulatory expert? A trusted partner who’s walked the same road before, and even has its own medtech products on the market. That’s the advantage of regulatory consultancy from Peercode. 

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How To Navigate A Labyrinth Of Legislation In The Medtech World
Mar 7, 2024

Medical devices have a direct impact on people’s health and the quality of care they receive from healthcare providers. For that reason, the medtech industry is tightly wrapped in regulation, and a product’s quality and correct usage are paramount. 

Legislation like the EU’s Medical Device Regulation (MDR) is there to enforce consistent and stringent standards for all. But, for medtech companies bringing products to multiple markets, it adds to a labyrinth of legislation. Here are our expert tips for navigating it.

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Decoding The Medical Device Regulation For Manufacturers
Feb 22, 2024

For medical device manufacturers, getting started with the EU’s Medical Device Regulation (MDR) is a huge challenge. With over 120 articles, close to 20 annexes, and more than 200 pages – plus all the accompanying guidance documents – it’s an enormous regulation to decode. 

Not only is it vast, the MDR also continuously evolves alongside the state of the art, new standards, and related regulations (such as the AI Act). Even for experienced compliance professionals, it can be a challenge to correctly decipher the MDR. 

To help you get started, here’s our outline of the best starting point for medical device manufacturers to dive into the MDR.

Knowledge center

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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.