Strict regulatory requirements, demanding material and tolerance specifications, and complete traceability call for strong technical expertise and certified quality management from a medical technology partner. Mectalent has served as a trusted product development and manufacturing partner for medical technology companies since 1996. The experience and expertise built up over the years, together with our ISO 13485-certified processes, ensure a compliant, high-quality result—whether the product is a surgical instrument or an implant placed inside a patient.
The EU Medical Device Regulation (MDR 2017/745) sets strict requirements for device safety and performance. These requirements cover the entire product life cycle, from design to manufacturing, testing, packaging, and delivery. Meeting them requires a design and manufacturing partner with documented processes, systematic risk management, and complete traceability. In practice, this means that every manufacturing step, material, and deviation must be recorded and remain traceable throughout the product’s entire life cycle.
Medical devices have very strict in-use requirements. Instruments often need a slim, low-profile structure along with durability across repeated use and sterilization cycles. In implants, the emphasis is on material biocompatibility, corrosion resistance, and strict surface finish standards.
For our medical technology customers, we manufacture a full range, from individual machined parts to subassemblies and complete assemblies. Material choice is highly application-specific, and we are experienced in working with titanium, stainless steel, and other medical-grade materials. Our specialists' deep knowledge of a wide range of materials and how they behave is one of our core strengths in medical device design and manufacturing.
Mectalent offers medical technology customers a comprehensive set of services from product concepting and development to manufacturing. We have extensive experience in the design of surgical instruments, implants and their insertion tools, and wearable electronics, among other products.
At the core of our design expertise are close collaboration between design and manufacturing, a strong understanding of materials, and a thorough knowledge of manufacturing methods. Thanks to our broad expertise, we design products that are high-quality, functional, and cost-effective to manufacture. This also shortens the lead time from design to production and smooths the start of manufacturing.
When needed, we use thermal simulation as part of the design process. Validating a product's performance and compliance virtually at the concept phase speeds up development and helps secure the quality of the final product.
Our medical technology customers have widely differing manufacturing needs, and we adapt to them flexibly. Our expertise in precision mechanics and demanding equipment manufacturing covers a broad range of machining methods, including CNC machining, 5-axis machining, EDM, and orbital welding.
Tolerance requirements depend on the complexity, size, and material of each part. In the most demanding cases, we reach tolerances measured in thousandths of a millimeter. When a controlled environment is required, assembly takes place in cleanrooms. ESD-protected areas are also available where needed.
Batch sizes range from prototype runs to continuous series production. Our extensive machinery, together with the added capacity from the acquisitions of TeknoComp and Avetak, means we can meet growing volume needs as well.
Our ISO 13485-certified quality management system covers the full life cycle of a medical device, from design to manufacturing. Meeting the standard's requirements—comprehensive documentation, complete traceability, systematic risk and change management, and attention to customer requirements at every stage—is a routine part of how we work.
For customers, ISO 13485 certification means certainty above all: every product and each step in its manufacturing can be traced across the entire life cycle. Any deviations are addressed systematically to identify the root cause, improve product safety, and minimize errors. On delivery, the customer receives technical documentation covering every stage of the manufacturing and quality assurance process.
>> Read the blog: ISO 9001 and ISO 13485 – quality that benefits our customers
GE Healthcare is one of the world’s leading companies in the medical technology field. Its products, solutions, and services help healthcare professionals diagnose, treat, and monitor patients.
One of GE Healthcare’s product groups is mammography systems. Mectalent manufactures parts for the Senographe Pristina™ system, used in breast cancer screening and diagnostics. In addition to component manufacturing, we are responsible for material procurement, coatings, laser marking, packaging, and manufacturing documentation.