Maatel support

Building customer trust

Creating sustainable

customer relations

We think further than the contract signature. Our customer relations are part of a long-term approach, with constant attention to your needs and requirements.

Customer relations are fundamental to all our activities - from the choice of the right dedicated contact for your project, through a genuine commitment to a successful project from the outset, to quality after-sales-service with ongoing support of all our products.

Our customer relations are built on respect and a trusting exchange - demonstrated by over 40 successful years in the business.

Our interactions

Confidentiality

At Maatel, we are particularly sensitive to your need for project confidentiality and the protection of your intellectual property.

Prior to any exchange of sensitive information about your project, we sign a written engagement not to divulge any information you share with us.

Also, contractually and after full payment, all studies conducted by Maatel for your project, including the analysis phase, become your property.

Responsible communication
Any Maatel communication regarding your products, via sales documents (brochures, videos, photos etc.) or in our exchanges with outside contacts, is subject to your prior approval.

Quality is our priority

Our quality control system: 40 years of expertise and mutual respect

With over 40 years in the industrial sector, and over 25 years in the medical sector, Maatel’s procedures and products are subject to thorough quality control.

Our quality control system has ISO 9001 certification, and our specific medical quality control system has ISO 13 485 certification.

We meet the EN 60601-1 and derivatives standard, general safety requirements, essential electrical medical equipment performance criteria, as well as the EN 62304 standard for medical device software, life cycle software processes.

Our quality control system covers every phase of your project, with a quality control process suited to each stage:

#1

During the product industrialization phase, a Full Process Chart (FPC) is established. This chart links each stage of the production process and details how risks will be contained during production. This document is used to validate each production process. The FPC has supporting documentation based on EN 13 485 standards for the medical sector and ISO 9001 for industrial products.

#2

All other quality standards and regulatory requirements are applied to complement the EN 13 485 and ISO 9001 standards. For example, the Maatel team has already acquired the expertise for quality and document processes required by FDA regulations for medical products sold in the United States.

 

All other quality standards and regulatory requirements are applied to complement the EN 13 485 and ISO 9001 standards. For example, the Maatel team has already acquired the expertise for quality and document processes required by FDA regulations for medical products sold in the United States.

Certification assistance

With thorough knowledge of our profession’s standard requirements, Maatel can assist you with each phase of product certification

Electronic and mechanic design

- Assessment of standard and regulation requirements
- Justifying technical choices

Verification

- Pre-qualification testing
- Supporting COFRAQ laboratory tests

Qualification

- Test compilation
- Construction of product files for CE, UTAC, UL and CSA, amongst others

Electronic production

- Ensuring compliance with IPC product requirements
- Traceability

Recognized standards and marks

CE marking

is required for the sale of electronic products in the entire European Union, and is recognised internationally.
Products are tested by an accredited body and meet the requirements set by pertinent European directives. The manufacturer makes a self-declaration. For Class I medical devices, the procedure is also a self-declaration by the manufacturer.

Enquiries

UL Listing marks

is issued by the Underwriters Laboratories. This shows that the product has been tested by a national testing laboratory and meets requirements for safety standards.

CThis brand is required regularly for the sale of electronic products in the American market. Maatel regularly assists their customers for obtaining the UL mark for their products, and is audited quarterly by UL experts.

Enquiries

The FDA (Food and Drug Administration)

regulates the sale of medical products, including medical devices, in the American market.

As the American counterpart of the European Medical Agency (EMA), accreditation by the FDA is essential for the distribution of medical products in the United States. Maatel has already assisted several customers in the medical sector for reaching compliance with the FDA 21CFR820 QUALITY SYSTEM REGULATION (QSR).

As a provider of electronic medical devices, Maatel has an FDA register number and our quality control procedures - such as documentation systems - comply with FDA requirements.

Enquiries

The CSA (Canadian Standard Association)

ensures the safety and compliance of products to Canadian standards. Like the UL mark, Maatel is audited every quarter for CSA compliance.

Enquiries

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