Specialized design in Electronic Medical Devices
MAATEL has NF EN ISO 13485 (V.2012) certification and a wealth of expertise in product compliance for European certification and accreditation by the FDA (Foods and Drugs Administration), the public body responsible for the safety of drugs and medical devices in the United States.
MAATEL’s experience is built on the design and production of electronic medical devices for over 25 years.
|Dir 93/42/EEC (class l, lla, llb, lll)
Dir 98/79/EC (class A, B, C, D)
MAATEL aims to grow their activity in compliance with European and international standards.
We are particularly attentive to our adherence with the latest regulatory requirements.
At Maatel, we apply the following standards:
For any medical device, containing risks is obligatory and stringent attention is required.
Risk analysis is conducted with you throughout your project: this first analysis allows for the identification of the criticality matrix. This matrix is fundamental to identifying critical points for design, and establishing the list of tests to conduct, as well as parameters to respect, either during prototype design, product industrialization or production.
These requirements are applied throughout the complete quality control system at each phase of the product life cycle.
Thanks to our experience in design and mass production of electronic medical devices, MAATEL is the best choice for analyzing the technical risk of your product with the application of stringent standards in monitoring.
Maatel’s expertise in risk analysis and management applies the requirements featured in the ISO 14971 standard for the “Application of risk management to medical devices”.
Version quality control
Applying standards to many medical devices requires your product and prototypes to be versioned.
This involves a range of practices, processes and tools to guarantee traceability of any product evolution, and a record of the complete history and all versions.
Maatel uses two ‘versioning’ tools:
Apart from compliance with medical standards, versioning tracks improvements for after-sales service of previous versions of your product, and to plan possible technical improvements.