Mechanical Production

ISO 13485-Certified Quality Management System

The workshop Quality Management System is certified according to ISO 13485. Depending on customer or project requirements, workshop outputs may support verification, validation, pre-clinical or clinical studies, usability studies, technical documentation, CE marking, notified body assessment, regulatory submissions, or other regulatory activities.

The workshop provides mechanical production services for prototypes, components, assemblies, test samples, and study-related materials made from metal and polymer materials, including stainless steel, titanium, aluminium, POM, PEEK, PMMA, and PTFE.

Services include CAD/CAM-based production preparation, precision CNC machining including milling and turning, fabrication, assembly, inspection, and prototyping or non-sterile parts and assemblies.

Project Classification

Projects are classified according to their intended use, regulatory purpose, and customer requirements.

Medical-device-related projects

These are projects where the manufactured outputs are intended to support medical-device design and development, verification, validation, technical documentation, CE marking, notified body assessment, regulatory submission, or other regulatory approval activities.

For these projects, applicable ISO 13485 controls are applied according to the agreed project scope. Depending on the project, this may include defined customer requirements, documented production steps, inspection, review, record control, traceability, and other applicable quality controls.

Research-only, non-medical, or non-regulatory projects

These are projects where the outputs are intended only for research, scientific, feasibility, educational, or exploratory purposes. These projects are also managed under the ARTORG QMS; however, the resulting prototypes, parts, samples, data, records, or reports are NOT intended to be used as evidence for CE marking, notified body assessment, regulatory submission, or medical-device technical documentation.

Contact us for an initial consultation, a workshop tour, or a quotation by e-mail or phone.

Training and Education for Polymechanics

The MDP group has a secondary role in education for Polymechanics. This education  encompasses the skills required to safely and proficiently operate machine shop tooling and equipment, the knowledge required to achieve the best results with a variety of materials and the skills needed to efficiently manage the design and production workflow.

Trial apprenticeships are used as a means to evaluate candidates for a full apprenticeship in the MDP group mechanical design and production needs. See the section "Jobs / Apprenticeship" for more information on our apprenticeship positions.