Supporting manufacturers with global regulatory approvals -- MEDICA - World Forum for Medicine


UL International Germany GmbH

Supporting manufacturers with global regulatory approvals

UL provides comprehensive services to support global regulatory submissions

UL provides resources to support manufacturers with global regulatory approvals
UL provides comprehensive solutions to support global regulatory approvals

UL is known for expertise, integrity and 3rd party safety testing. With UL's Health Sciences team, you also have access to all the services needed for complying with regulatory requirements around the world.

Download our brochure at to see our full suite of services in more detail.

Solutions include:

3rd party regulatory approvals: EU Notified Body, MDD, IVDD, Japan PAL, Saudi Arabia

Management Systems Certification: ISO 13485, CMDCAS, ISO 14971,

Safety testing & certifications: IEC 60601, IEC 61010, Brazil INMETRO, IECEE CB Scheme

Software certification: IEC 62304, IEC 60601 Clause 14

Health IT and Interoperability: Testing and Continua Test Lab

Pre-Clinical testing: Biocompatibility ISO 10993, Physical and Chemical testing, Microbiological testing

Ophthalmic testing

Packaging and Transportation testing, Shelf life testing

Validation of cleaning, reprocessing and sterilization

Human Factors Engineering & Usability: IEC 60601-1-6, ISO 62366, HE-75

CRO: ISO 14155

EMC: IEC 60601-1-2, EMC CBTL, FCC Part 18 and 15B, IEC/EN 61326-1, IEC/EN 61326-2-6

Knowledge solutions, Training and more

Links and Resources:

View Customer Testimonials and our 2-minute video:

Previously published articles are found at:

The Health Sciences Global Regulatory Digest back issues may be downloaded from the UL Library at

Find UL White Papers -

View our full Human Factors Engineering capabilities at

View UL’s comprehensive services for the Medical industry at

Dedicated web page with resources for IEC 60601: