Calenco for
medical device manufacturers

Improve compliance, traceability, and the updating of your regulatory documentation

An industry where precision, compliance, and traceability are vital

In the medical device sector, every document can have a direct impact on patient safety, regulatory compliance, and market access.

Multilingual IFUs, technical files, quality documentation, audit reports, validation tests, or post-market documentation… volumes are high and requirements are very strict. Yet many companies still rely on Word or InDesign, multiplying copy-pasting, manual approvals, and long, error-prone reviews. The slightest deviation can lead to MDR non-compliance, market launch delays, or weakening of the quality system.

Calenco enables you to structure, centralize, and automate all your medical device documentation, providing your teams with a reliable, traceable, and regulatory-compliant environment.

Documentation Challenges in the Medical Device Sector

Multiple versions of IFUs and manuals in various languages.

Risky copy-pasting that can alter critical information.

Delays in regulatory updates related to MDR or product changes.

Internal and external audits requiring full traceability of changes.

Paper-based or non-digitized field reports.

Complex layouts that are time-consuming to maintain in compliance with guidelines and standards.

In an environment governed by the European MDR, ISO 13485 requirements, and competent authorities, document control is not optional. Calenco transforms these constraints into a structured, reliable, and automated documentation workflow.

Calenco helps you produce, structure, and keep up to date:

Multilingual IFUs and user manuals

Technical files and CE marking documentation

Quality documentation (ISO 13485, QMS, procedures, records)

User manuals and training materials

Audit, testing, and qualification reports

Check sheets, checklists, and field forms

Clinical and preclinical documentation

Free trial

1 platform, 2 solutions to master your entire documentation lifecycle

Calenco Docs: Take control of your critical content with full compliance

Calenco Docs centralizes and structures medical device documentation into reusable modules. Every update to a paragraph, warning, or procedure is automatically propagated across all related documents, with no risk of omissions or errors. For RA, QA, technical documentation, and R&D teams, Calenco becomes a cornerstone of the quality system and regulatory compliance.

Ensure full compliance and complete traceability of your content.
Precisely manage versions and document dependencies.
Automate layouts, including complex IFUs.
Streamline multilingual management with translation memories.
Publish in one click in all required formats (PDF, Web, tablet).

Explore the possibilities

Calenco Forms: Reliable field data, even in regulated environments

Calenco Forms digitizes your field forms, quality audits, inspection sheets, and qualification reports. Data is collected directly on tablets, online or offline, and automatically synchronized with your quality environments.

Collect reliable data directly on site.
Eliminate double data entry and associated errors.
Automatically generate audit and qualification reports.
Connect data to your QMS or internal tools.
Strengthen traceability and compliance of field operations.

Discover the features

They trust Calenco in the medical device sector

Supersonic Imagine

Automation of medical imaging documentation

Supersonic Imagine centralized all its documentation in Calenco and cut in half the time required to update its multilingual manuals, while ensuring compliance, graphical consistency, and full traceability.

Soluscope

Industrialization of 400 technical documents in 20 languages

Soluscope structured its manuals into reusable modules and automated multilingual translation, reducing creation time by four and update time by five, while strengthening international compliance.

Hücker & Hücker

Digitization of medical equipment audit reports

With Calenco Forms, field teams complete their audits on tablets, automatically generate reports, and eliminate double data entry—significantly reducing lead times and improving data reliability.

Discover our case studies