Access to Infrastructure & R&D Support service
Healthcare and Medical devices testing services
Provided by DEKRA Testing and Certification SAU · Spain
Service description
Through this service, DEKRA offers accredited electromagnetic compatibility (EMC), Radiofrequency (RF), Safety testing services tailored for healthcare industry, including In Vitro Diagnosis and Dental Equipment, under ILAC recognition. The duration of the service depends on the scope and complexity of the required tests, which will be defined during the initial evaluation in accordance with applicable standards. Manufacturers of Active Medical Devices, Dental Equipment, IVDs, Aesthetic Equipment and other Healthcare equipment must comply with technical standards such as IEC 60601-1 series, ISO 80601 series, IEC 61010 series, IEC 62304, and other sector-specific requirements. DEKRA aim is to ensure safety and security through validation, by verifying product compliance with strict operational, environmental, cybersecurity and radio performance standards, ensuring MDR/IVDR readiness.
Service phases: 1) Initial project evaluation and planning, 2) Sample preparation and reception, and 3) Test execution Delivery of accredited reports. The lead-time strictly depends on product complexity and the cost is dependent on product complexity. The activities delivered will be, a) EMC testing: emissions and immunity (conducted/radiated), ESD, electrical transients, pulses, discharges, proximity magnetic field, H-Field immunity; b) Radiofrequency testing: verification of transmission characteristics and coexistence for wireless devices; c) Safety testing: general safety, temperature, humidity, vibration, corrosion, thermal shock, fluids, and others; d) Cybersecurity evaluation (penetration testing. Fuzz testing, vulnerability detection); e) Testing according to IEC 60601/61010 series, and related standards. Once all the necessary testing is performed, DEKRA will deliver accredited test reports showing compliance with the applicable standards and regulations. The service is conducted primarily at DEKRA's laboratory in Spain, equipped with EMC anechoic chambers, safety testing facilities, and radio testing infrastructure suitable for high-demand applications.
The services are custom made based on the needs of client. The quotation will vary depending on the Equipment Under Test specifications, RF interfaces and final use/sector. These will determine the standards applicable for testing. Additionally, the scope and markets of destination will determine the kind of certifications applicable and our quotation will vary accordingly.