Navigating the Path to European Market Access
The CE mark is a mandatory conformity marking for products sold within the European Economic Area (EEA). It signifies that a product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements. Navigating the directives and harmonized standards required for CE Marking can be a complex process.
BQCIS provides comprehensive support to guide your product through the entire conformity assessment procedure. Our technical experts help you identify the applicable directives, conduct the necessary safety and performance testing in our accredited laboratories, and assist in compiling the mandatory Technical File and Declaration of Conformity. We streamline the path to compliance, enabling you to affix the CE mark with confidence and access over 500 million consumers.
Our CE Marking Process
Key Benefits of Our Inspections
Prevent Costly Downtime
Identify potential equipment failures and structural issues before they cause unexpected and expensive operational shutdowns.
Ensure Workplace Safety
Mitigate risks and ensure your facility complies with all health and safety regulations, protecting your employees.
Optimize Maintenance Budgets
Our reports provide the data you need to prioritize repairs and allocate your maintenance budget effectively.
Verify Asset Value
Receive an independent, third-party condition assessment to support commercial transactions like sales or leases.
Success Story
Achieving CE Certification for an Electronic Medical Device
A startup developed an innovative electronic medical device but needed to navigate the complex Medical Device Regulation (MDR) and other directives to achieve CE Marking for a European launch.
BQCIS provided a complete compliance pathway, including identifying all applicable standards, conducting electrical safety and EMC testing, and compiling the extensive technical documentation required for the Notified Body review.
The client successfully passed the Notified Body audit and obtained their CE certificate. Their device was launched on schedule in Germany and France, establishing a strong foothold in the European market.