Medical technology – testing and certification at the VDE Institute

Online consultation days

Safety requirements of clinical thermometers and febrile screening thermographs according to ISO 80601-2-56 and IEC 80601-2-59

The event is a free online event. Contents of the event:

Overview of the related regulatory requirements
Safety concepts
Testing requirements
Labelling requirements
Related Usability and Home healthcare requirements

In medical technology, the utilized products are required to meet regulatory and normative requirements. With the expertise of our VDE experts, our years of experience and our extensive scope of accreditation and recognition in the field of medical technology, we offer you various services so that your medical product can meet current market demands – even as early as during the development process. By doing so, differences can be quickly detected and resolved. Not only does this save money during product development but also time during the subsequent certification.

Our activities focus on the following fields

Dental treatment units

Treatment units constitute the basis for successful and efficient dental treatment. Furthermore, they lay the foundation for a positive patient experience.

Relevant standards:

DIN EN/IEC 80601-2-60
DIN EN ISO 7494-1, 7494-2, 9680

Operation tables

Only through professional patient positioning can complex surgical interventions be performed with a high level of patient safety. Even ergonomic aspects of the persons being treated must be taken into account here.

Relevant standards:

DIN EN/IEC 60601-2-46

Monitor with heart rate during an operation

Patient monitoring (EKG, SpO2, Temp, NIBP, etc.)

Safely measuring and displaying physiological parameters are the foundation for successful patient care.

Relevant standards:

DIN EN/IEC 60601-2-25
DIN EN/IEC 60601-2-27
DIN EN/ISO 80601-2-55
DIN EN/IEC 80601-2-49
DIN EN/ISO 80601-2-56
DIN EN/IEC 80601-2-30
DIN EN/IEC 60601-2-34
DIN EN/ISO 80601-2-61

Endoscopic systems

These minimally invasive diagnostics and treatment techniques result in shorter stay times for patients and reduce the risk of infection.

Relevant standards:

DIN EN/IEC 60601-2-18

Medical software

Nowadays, there is hardly any medical product that can make do without firmware and/or software. An increasing number of apps are also standalone medical products in their own right. We verify compliance with normative and regulatory requirements on your behalf.

Embedded or standalone software that is marketed as a medical product must fulfill special requirements. In addition to safety and effectiveness, they also include the definition and application of software life-cycle processes.

To fulfill the regulatory safety and performance requirements for medical software, the implementation of the IEC 62304 process standard is internationally accepted as the current state of the art. Based on the risk management process according to ISO 14971, the standard defines requirements for the life-cycle processes and the technical documentation that must be taken into account when manufacturing and servicing medical software.

Due to the high market requirements and the associated cost pressure, cross-product establishment and applying life cycle processes in a manner that is tailored to continuous optimization during the creation of medical software has become a critical factor for success.

To certify the conformity of your life-cycle processes with IEC 62304 requirements, our neutral experts conduct a multi-level process audit. Once all the requirements have been met, it is certified with the certification and issuance of the VDE quality seal, "Certified Life-Cycle Processes". Manufacturers and service providers that develop medical product software can use the VDE quality seal for advertising purposes and place it on brochures or publish it online, for instance.

The certification process is closely aligned with the DIN EN ISO/IEC 17065 standard and comprises a 3-year audit cycle, consisting of an initial certification audit and two monitoring audits. One evaluation of the established lifecycle processes, the continuous improvement process and a random inspection of the technical documentation takes place per audit unit.

Benefits for you

Ensure a standards-compliant software development process across several product groups, service areas, or development departments
Legal and planning certainty when entering markets
Continuous feedback regarding potential for improvement
Information on current developments in the relevant standardization bodies
Economic benefits during process certification if the medical software is often updated in short time intervals, developed at a large scale, or used in various medical equipment
Cost reduction of up to 30% for medical equipment software tests that must be performed by the VDE Institute as part of electrical safety according to IEC 60601-1
Use of the VDE mark as a quality seal for OEM manufacturers and development service providers

In the field of medical technology, the sterile laboratory equipment, among other things, is tested.

Incubators, cleaning, disinfection and sterilization equipment and laboratory freezers

Reliable and safe laboratory equipment is required for safe laboratory operation and optimum care with clean medical products and sterile materials.

Relevant standards:

DIN EN/IEC 61010-2-010
DIN EN/IEC 61010-2-011
DIN EN/IEC 61010-2-012
DIN EN/IEC 61010-2-040

Laboratory and IVD equipment

The basis for a high level of patient safety is reliable diagnostics in the laboratory. To protect the user group of this equipment, the VDE Institute offers testing services for it.

Relevant standards:

DIN EN/IEC 61010-2-020
DIN EN/IEC 61010-2-051
DIN EN/IEC 61010-2-081
DIN EN/IEC 61010-2-101

An overview of our services

For years, the medical technology industry has been characterized by a high level of innovative force and is number one in patent applications. Its fast-paced development, which is also due to the complexity of digitalization, continuously entails new normative requirements for medical products. This is why early collaboration with the VDE Institute is recommended.