Standardization

Standardization and technical documentation

We establish a clear requirements framework for production, control and product assessment. Documentation is based on the manufacturer’s actual data and applicable normative requirements.

Applicable standards

We identify documents by intended use, design, parameters and market, considering scope, applicable edition and procedural conditions.

Organization standards and technical specifications

Product requirements, acceptance rules, control methods, marking, packaging, transport and storage tailored to the enterprise.

Technical product passports

We organize specifications, manufacturer information, supplied components and conditions of use based on drawings and specifications.

Operating manuals

Installation, safe operation, maintenance, transport and storage, taking account of product design and intended use.

Documentation updates

We check consistency of models, parameters, terminology and references, including design and regulatory changes.

International projects and deliverables

We prepare technical materials for CE and applicable FDA requirements. Management system documents are developed within implementation projects. Deliverables, inputs, schedule and pricing are agreed before work starts.