The medical industry

Testing and quality control solutions carried out in compliance with the ISO13485 standard
Solutions for the medical industry
Testing and quality control of medical devices
An ISO13485 certified organization that takes into account the specificities of the medical industry

qmt is a specialist in the creation of testing and quality control systems. For more than 20 years, we have been producing this type of solution for medical applications in Switzerland and France. We have put in place an organization particularly suited to the needs of this industry. It includes rigorous project management, risk management, design procedures taking into account the system architecture.

The strengths of a collaboration with qmt
  • The management system certified ISO 9001 and ISO 13485
  • Project management and architecture
  • Project process and risk management according to FMEA
  • A medical standard for IQ / OQ / PQ qualifications
 
qmt customization programs
Fit For You (qmtF4U)
Personalization
some products

Personalization
some products

QMTF4U PROGRAM
MADE FOR YOU (qmtM4U)
Workaround on
measure

Solution according to specifications
charges

QMTM4U PROGRAM
OEM (QMTOEM)
Your
Product

Custom product
industrialized by qmt

QMTOEM PROGRAM
qmt is the project manager
Commitment to results
Our clients secure their investments with qmt

The qmt organization is very “customer satisfaction” oriented. A project team is appointed at the start of development, it works in accordance with the project process which guarantees the achievement of the client's objectives in terms of planning, quality, costs and performance.

QMT projects are based on customer specifications (URS). qmt completes the specifications with a “Response to Needs (RB)”. This document commits qmt to achieving the proposed performances within the defined limits.

 
More information and examples of achievements with the presentation Detailed presentation
SAVE TIME AND EFFICIENCY
qmt offers the definition of requirements in collaborative mode
An ISO13485 certified service

Defining requirements for a new test or quality control system is often a bottleneck for project initiation. It represents an effort and a delay for the customer but also for the supplier who must respond to the requirements.

qmt offers the definition of requirements collaboratively in the form of a sprint to address the presentation of the context and issues, the expression of needs, the definition of constraints, the formalization of requirements, the FMEA risk analysis and the validation of specifications with the customer. During this sprint, the validation methods are also defined to integrate the validation constraints in the design and production phase. is also initiated. The deliverables of this phase are:

  • Horned beast
  • Functional analysis
  • Specification in the form of response to needs
  • FMEA risk analysis according to ISO14971
  • Validation protocol according to current standards (ISO13485, CFR21Part11, IEC 60601-1-11, etc.)
From SMEs to multinationals in various industries
Over 100 customers have trusted qmt
SAVE TIME AND EFFICIENCY
qmt offers the achievement of medical qualifications
An ISO13485 certified service

The validation effort in the medical field is high and represents a significant completion time which can compromise the success of the project.

Basically, qmt carries out the FAT and SAT according to the client's validation protocol to facilitate final qualification by the client (IQ, OQ and PQ), qmt also provides the system's documentary package. QMT support can continue after the SAT with the provision of a resource to support the customer during the qualification of the equipment

qmt offers a 2nd qualification mode with parallelization of the efforts of qmt and the client to reduce the implementation time. qmt can also take responsibility for this qualification with a resource seconded to the client's premises.

From Optics to Mechatronics Inspection
All the know-how for solutions mastered by qmt

The guarantee of a high-performance solution that meets specifications

Understanding of the need and technical coordination for a complete and turnkey solution

Software development with acquisition, processing and ordering

Design, assembly and development of mechanical systems

Design of analog and digital electronics

Calculation, definition and realization of optical systems

Acoustic

Mastery of the acquisition of vibratory signals, their processing and analysis

Data Science

Mastery of data backup and their analyzes to learn, control and anticipate

Example of a medical measuring station
High speed control of pipettes with qmtsort-tip
Pipettes are used in the medical industry to perform small volume dosages. To guarantee the precision of this dosage, the pipette tips must have perfect geometry and surface condition. The plastic injection production process for pipette tips does not allow 100% quality control. 100% automatic control is therefore necessary
More information
Example of custom equipment
A testing device for the medical industry
qmt supported its client in setting up an automated quality control for a woven component at the end of production. High added value and innovative products must be 100% checked at the end of production to ensure that they are free from defects. The control device has been developed in accordance with the ISO1385 medical standard including all the validation phases which have been managed by qmt.
More information