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COMPLIANCE FOR YOUR MEDICAL DEVICE

Empower your team with smart documentation: Connect digital data and boost efficiency with ColabON's intelligence.

List of applied standards and regulations

Success Through Reliable Information: Standards and Regulations for Medical Devices - 3 Success Factors

Most Important Links to Regulations and International Standards Medical Devices

EU-AI Act and Medical Devices: Looking for Manufacturers for a Semester Project on Compliance Assessment

Understanding SN EN ISO 13485/A11 2021 and its role in medical device compliance

VISION

More time for your innovation

Benefit from:

Continuously updated regulatory data
Automated impact analysis of regulatory changes
Intelligence for efficient quality management systems and technical documentation

Orthopedic Medical Devices

ALWAYS UP-TO-DATE DATA

We assist you in selecting all harmonized standards (for MDR or IVDR). With ColabON, you gain an overview of all requirements, and all this comes at an attractive package price.

Data is always up to date
High-quality data at the requirement level
No more manual updates required

Always Current Data

Online interpreation

INTERPRETE ONLINE

Our SaaS platform enables effortless assessment of regulatory requirements.

Connect these requirements to process and product specifications.

Benefit from the knowledge and examples from standards and the ColabON Proposal.

REAL-TIME INFORMATION

Are you prepared for the upcoming audit?

Real-time traceability offers swift and precise insights, enhances efficiency, improves transparency, and allows for rapid adaptation to changes in processes and product requirements.

Effortlessly generate compliance reports for export.

Applicability Status Report

X-Ray of hand: owen-beard-DK8jXx1B-1c-unsplash

ColabON IN NUMBERS

31

Standards and regulations

13532

REQUIREMENTS

9

PARTNER

216

ColaON Proposals

WHY COLBON

Compliance made easy

ColabON delivers the following benefits:

Cost-Effective Digitization: ColabON reduces your digitization costs, saving you time and effort.
High Data Quality: We provide reliable, legally compliant, and constantly updated information.
Instant Traceability: Traceability is just a click away.
ColabON Proposal: Take advantage of our unique ColabON Proposal feature.

INDUSTRY

Our partners

"In our previous system, it took months to identify gaps in SOPs. The discovery took far longer than the actual closure."

Corporate Head of QA/RA

Do you have any questions?

ColabON Team

Contact

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