Comate – Certification (CE/FDA, MDR/IVDR, RED/EMC, ISO 13485).

What is this?

Comate provides support around certification, compliance and quality processes to get devices, machines and hardware products ready for market launch.

They help you define the right regulatory and certification strategy (EU/US or multiple regions) and support the track from early development to (pre-)compliance and formal testing.

When is this relevant?

This is especially useful if you:

• want to bring a device/machine to market and need to demonstrate CE marking or other compliance
• operate in a regulated sector (e.g. medtech)
• want to avoid delays or redesign by considering certification from day one
• need to choose a test lab and want clarity on what to test and when (pre-compliance vs formal)

What can Comate support with?

Based on the page:

• Defining a certification strategy: which standards/directives apply to your product and target markets?
• Documentation & guidance: providing the right evidence for testing and audits
• Setting up a test strategy (including critical pre-compliance tests)
• Selecting accredited labs that fit your product
• Support for testing in areas such as radio spectrum, safety, EMC and cybersecurity
• Advice on how design choices (components, architecture, …) impact compliance and performance

Examples of compliance frameworks (as listed)

• MDR 2017/745
• IVDR 2017/746
• Machinery Directive 2006/42/EU and Machinery Regulation (EU) 2023/1230
• Low Voltage Directive 2014/35/EU
• Radio Equipment Directive (RED) 2014/53/EU
• EMC Directive 2014/30/EU

ISO 13485 (medtech)

Comate notes they work with an ISO 13485-certified QMS for developing medical devices.

Practical tips

• Include certification early in development to avoid rework.
• Be clear about target markets (EU/US).
• Separate pre-compliance engineering from formal lab tests and plan prototypes accordingly.

Link

• Certification | Comate