Medical product development requires expertise and specific knowledge (about ISO 13485, MDR, …). We offer a complete package, from product development to innovation management and QARA.
Innovation in Healthcare
A shift within the Healthcare industry
There are few sectors where innovation can have such a profound impact on people’s lives as in the Healthcare sector. It is also one of the most regulated sectors where patients' lives are literally at stake, and patient and caregiver safety are absolute priorities.
At Comate our Healthcare team is 100% focused on supporting our customers in the development of innovative new medical products that change patients' lives. We offer end-to-end services that cover the whole journey from an innovative idea all the way to a completely engineered and developed product ready for large-scale manufacturing and certification.
With over 10 years of experience with medical device development, Comate is the expert partner to support you in the development of your next medical innovation. Be it a set of surgical instruments, a wearable for patient monitoring, an IVD point-of-care device, or rehabilitation equipment.
Comate is ISO 13485 certified
Within the medical device industry, standards are defined to ensure quality and reliability throughout the entire product life cycle, including product design. The ISO 13485 standard defines a broad range of requirements on quality management systems (QMS) for medical devices and equipment.
Comate implemented a quality management system that is compliant with the ISO 13485:2016 standard. This means we have processes in place that indicate possible risks towards patient safety and that take the necessary measures to reduce these risks as much as possible. This quality accreditation ensures that our products are designed and delivered to the highest standards as part of a fully controlled process.
Our approach, processes and competences are completely geared towards giving ideas the best chance to succeed. In the Healthcare space this means developing innovative medical products that improve patient and caretaker’s lives in a safe, (cost-)efficient and easy-to-use way.
Since the medical device space is highly regulated, Comate has developed a formal design process to ensure that the design is produced in a controlled manner and that all unacceptable risks have been mitigated. This process at Comate consists of 4 high-level phases:
- Initiation phase
- Concept and Feasibility phase
- System Development and Verification phase
- Industrialization and Design Transfer phase
Comate supports this whole process with QARA (Quality Assurance and Regulatory Affairs) activities to ensure that the development of your devices is done in compliance with applicable regulations, a critical step in the certification of your device.
Comate works with external partners to support other aspects of the medical device development, such as IP management, pre-clinical and clinical testing/validation, manufacturing, and regulatory submission.
Starting a project
A new project always starts with an in-depth discussion between Comate experts and the customer. Based on this discussion Comate determines what resources and expertise the project needs, and how the project will be set up. This is captured in a Project Plan that includes a description of the tasks, estimated timelines and costs, and deliverables. If the proposal meets the customer’s expectations, the project is initiated with a kick-off meeting between all stakeholders.
From the very first discussions a project manager is assigned to the project and will lead the project from start to finish. The project manager acts as the main point of contact and provides regular updates on project progress and budget.
In order to develop medical products that are a success in the market, Comate brings together a range of different competences that each play an essential role in the development process.
- Industrial Design
- Mechanical Engineering
- Electronics Engineering
- Software/Firmware Engineering
- Human Factor and Usability Engineering
- Quality Assurance and Regulatory Affairs support
At the start of a new project, Comate lists all the standards that are applicable to the product and its intended use. Throughout the development care is taken to follow these standards to ensure that your product is fully compliant. Examples of such standards include:
- ISO 13485 for Quality Management Systems
- MDD and MDR for production and distribution of medical devices
- IEC 60601 for medical electrical equipment
- IEC 62304 for medical device software
- IEC 62366 for usability engineering
- ISO 14971 for risk management
- Radio Equipment Directive (RED)