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Medical product development requires expertise and specific knowledge (about ISO 13485, MDR, …). We offer a complete package, from product development (mechanics + electronics) to innovation management and QARA.

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, we are 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 certification ensures that our products are designed and delivered to the highest standards as part of a fully controlled process.

Comate and Zenso - electronics specialist within medical sector - join forces

In 2022, we joined forces with electronics specialist Zenso. These experts have impressive experience in delivering design and integration services for class I, II and III medical devices and AIMD, supporting their customers in all phases of development compliant to the medical device directive. Most impressive: their unique experience in the development of implants and neurostimulators.

Approach

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.

More about QARA

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Competences

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.

These include:

Industrial Design
Mechanical Engineering
Electronics Engineering
Software/Firmware Engineering
Human Factor and Usability Engineering
Quality Assurance and Regulatory Affairs support

Regulatory compliance

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)

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.

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