HL Technology Press Release

A medical, dental or orthopaedic device project doesn’t always follow the same path. Some clients hand us the entire journey, from concept to market; others simply need one precise link in the chain. That’s the whole idea behind our One Stop Shop model: six independent steps, to be engaged as needed.

• Manufacturing & Packaging — Swiss turning, milling and EDM, injection molding and silicone overmolding, laser welding, heat treatment, surface finishing, laser and pad marking, precision cleaning, assembly, sterilisation and sterile packaging — and many more.
• Brainstorming & Discovery — user needs and risk analysis
• Design & Engineering — design inputs, specifications, DFMEA
• Verification & Validation — testing and clinical evaluation
• Technical Files — complete regulatory documentation
• PMS — post-market surveillance, PMCF and periodic safety reporting

This flexibility isn’t just about how a project is organised: every step comes with regulatory compliance built in — CE marking (MDR 2017/745) for the European Union, MedDO compliance for Switzerland, FDA registration for the United States, and internationally recognised ISO 13485 certification.

A recent example illustrates this flexibility well: a client originally approached us to machine a simple titanium micro-tip. The project ended up growing into a complete finished product — packaging, quality control and regulatory validation included. That’s the whole spirit of the One Stop Shop model: the client stays in control wherever they choose, and we take over as far as needed.

« What matters isn’t doing everything for every client: it’s that they know exactly what they’re handing us, and that boundary never affects the compliance of the final product. »

— Mickael Risold, CTO / Business Development Director

Have a project in mind, or a question about one of these steps?

Get in touch — we’ll find the right fit together