medical products

From interpretation of standards to risk management, testing and certification, EUROLAB provides Total Quality Assurance throughout the product life cycle. Test and present your medical device to your customers faster than ever before. Time to market begins with partnership, and EUROLAB partners with medical device manufacturers to develop product assurance and global regulatory solutions for testing, certification and inspection.

EUROLAB consultancy and assurance services for medical devices are carried out by medical device specialists of a separate legal entity that have no impact on any aspect of the activities of the EUROLAB Notified Body.

Regulatory Requirements for Medical Equipment
Market your medical device with a partner who can help you guide regulatory requirements for IEC 60601-1, IEC 60601-1-2, MDD, IVDD and CB Diagram.

Medical Product Testing Solutions
Reach your target markets quickly and cost-effectively with electrical, software and mobile application testing and certification for your medical device.

Environment and Regulatory Services
We fully support the medical device industry to comply with global health and environmental regulatory requirements and restrictions, such as RoHS.

Medical Management Systems Certification and Audit
Access the market faster with integrated compatibility solutions and a global team.

Scientific Support Services
Medical device and material testing such as extractable / leak safety assessment and bioassay supporting all stages of development and production

Clinical Research Services
Multidisciplinary clinical teams offering robust, GCP and ISO 14155 compliant clinical trials for low-risk medical devices.

SPE-3000-15
It acts as a model code for field assessment of medical electrical equipment (MEE) and medical electrical systems (MES), in particular with regard to protection from electric shock, fire and mechanical hazards.