Danaher follows all laws and regulatory requirements governing the development, manufacturing, distribution, marketing, government contracting, sale and promotion of our medical products. We are also committed to maintaining an open, constructive and professional relationship with regulators on matters of regulatory policy and submissions.
Medical Technology Compliance
Some Danaher Operating Companies produce and sell medical devices and other products that are regulated by the United States Food and Drug Administration (the FDA), and by similar agencies in other countries.
The product quality and safety requirements for these products are extensive and complex, and failure to comply can have significant consequences. Always be sure that medical technology products strictly comply with all applicable rules, regulations, and guidance.
Product Quality and Safety
Our medical product customers rely on Danaher for industry-leading, safety, product quality and reliability. Each of us has a role to play to ensure that we are accountable for the quality of our products. We also hold our suppliers and distributors accountable to ensure the quality of the products and services they provide.
If you learn of any quality problem associated with our medical products, you have a responsibility to promptly report it to Operating Company’s customer service or complaint-handling unit.
We understand and follow the strict regulations that govern our promotional activities and our educational and commercial relationships with healthcare professionals. We promote our medical products solely based on their approved labeling, and we sell our products through accurate and truthful communications.
All information provided to others about our medical products must be truthful, balanced and supported by data and relevant experience. All materials created for use in promoting our products must be reviewed and approved through the proper channels.
We always obtain the appropriate legal and regulatory approvals for our medical products. Since approvals are unique to each country, we follow the specific requirements for the marketing, sale, and promotion of our products in that country.
We are committed to ensuring the safety, privacy and well-being of the patients who volunteer in our clinical trials. We meet all regulatory requirements as well as the highest ethical, scientific and clinical standards in all of our research initiatives worldwide.