Certification

Bringing a device or machine to market isn’t just about engineering. It's also about compliance and quality. At Comate, we help you navigate the complex landscape of regulations, directives and certification strategies. From early development to final testing, we ensure your product is compliant, credible and ready for launch.

Whether you're targeting the EU, the US or multiple regions, we help define the most efficient certification path. Our team supports you with documentation, testing strategies and lab selection, while keeping quality and compliance top of mind throughout the design process.

The challenge

Certification is often underestimated, until it causes delays, extra costs or redesigns. Common challenges include:

Navigating complex regulations confidently by building regulatory expertise into your development team.
Strengthening your certification journey by aligning test strategies with long-term product goals from day one.
Boosting efficiency and reliability by partnering with accredited labs that match your product’s specific needs.
Streamlining certification by clearly distinguishing between pre-compliance engineering and formal testing phases.
Ensuring smooth lab testing by preparing high-quality samples and thorough documentation early on.
Achieving compliance while preserving product functionality and scalability through smart, integrated design choices.

Our approach

Together, we define the most effective certification strategy based on the product’s functionality, stakeholder needs and intended market. With extensive experience in navigating a wide range of regulations and directives, we guide the process from engineering to compliance for all products requiring FDA or CE marking (under MDR, IVDR, RED, EMC and more).

We help select the most critical pre-compliance test cases, identify accredited test labs with relevant expertise, and support testing for radio spectrum, safety, EMC and cybersecurity.

Drawing on insights from past projects, we advise clients on the impact of design decisions, from component selection to system architecture, ensuring compliance without compromising product performance.

Compliance & standards

The right certification path depends on your product’s type and functionality. We help identify and apply the relevant frameworks, including:

MDR 2017/745 – Medical Device Regulation
IVDR 2017/746 – In Vitro Diagnostic Regulation
Machinery Directive 2006/42/EU
Machinery Regulation (EU) 2023/1230
Low Voltage Directive 2014/35/EU
Radio Equipment Directive (RED) 2014/53/EU
EMC Directive 2014/30/EU

For medical devices, our ISO 13485-certified QMS ensures development aligns with industry expectations. We also support cybersecurity assessments and software validation where needed.

ISO 13485

In the medical device industry, quality and reliability are safeguarded through strict standards, including ISO 13485, which outlines requirements for quality management systems. At Comate, we work according to our ISO 13485 certified QMS, ensuring that risks to patient safety are identified early and mitigated effectively. This certification reflects our commitment to designing and delivering medical devices through a fully controlled, high-quality process.