PEERCODE Regulatory Consultancy
We offer clients quality and regulatory services, auditing, training and assist in bringing medical devices to market
We offer the following services to support your company with quality-, law- and regulatory-based challenges in the field of medical devices.
It’s no secret that an effective Quality Management System (QMS) is essential for compliance with the EU’s incoming Medical Device Regulation (MDR) as well as ISO 13485 certification.
First published in 2017, the EU’s Medical Device Regulation (MDR) became mandatory for medical device companies in 2021. However, there are still many devices on the market with MDD certificates. These will soon expire or require attention before 2024 – even with the planned extension to the MDR transition period.
It might be a voluntary certification for the quality management of medical devices, but ISO 13485 is considered by many to be the gold standard. In fact, as many medical device companies already know, obtaining this standard helps smooth the path to compliance with the European Union’s latest Medical Device Regulation.
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.
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.
“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
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:
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.