PEERCODE Regulatory Consultancy
We offer clients quality and regulatory services, auditing, training and assist in bringing medical devices to market
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.
“Peercode’s project assistance, clinical writing and quality review was of tremendous value for our clinical trial submission. In particular the advises given and the added knowledge on the MDR requirements has made a difference.
We feel we went through a great learning experience with a great outcome. We would recommend Peercode to anyone when seeking Medical Device consultancy.”
Aylvin Dias, Principal Scientist & Project Lead – Implant trial DSM
Companies that develop Medical Device Software (MDSW) need to consider both the requirements of the EU’s Medical Device Regulation (MDR), and the standard IEC 62304. That’s because the software development practices, outlined in IEC 62304 – Medical device software: Software life cycle processes help to ensure that standalone software, or software components designed to be used alongside or in combination with a medical device meet the safety and performance requirements set out in the MDR. Here’s what makes it essential for makers of MDSW.
Getting a medical device market-ready is a key milestone. That’s largely because meeting regulatory requirements – like the EU’s Medical Device Regulation (MDR) – is such a huge challenge. Regulatory consultancy can help. The big question is of course how much that costs. How do you put a price on getting the right support with regulatory compliance?
Risk – or more precisely, risk management – is an important aspect of any marketable product. For medical devices, where patient and user safety is paramount, it’s especially important to manage and mitigate potential risks. That’s because a malfunctioning or faulty device could result in harm or even death.
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.).
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.