Medical Industry Services
Henkel recognizes that product quality assurance is of paramount importance to medical device manufacturers. The risks associated with poor quality range from the lesser extreme of monetary fines to the worst extreme of loss of human life. As a result, medical device manufacturers are challenged with stringent validation and qualification procedures.
Henkel offers unique services to our medical device clients to support them in every phase of device qualification and validation. From engineering support in the early design phase with adhesive selection and application guidance, to industry-specific quality controls to ensure a consistent and high reliability process in the validation phase, our Engineering Services, Quality Control, and Training Programs have been developed specifically with medical device manufacturing in mind, including:
- Medical Engineering Services
- Medical Quality
- Medical Training
Henkel understands the critical validation process that medical device manufacturers must undergo to ensure the efficacy and safety of new devices. Although adhesive and material suppliers have no specific regulatory requirements regarding biocompatibility testing, Henkel’s ISO 10993 adhesive biocompatibility program is the most comprehensive in the industry and includes the following tests:
- Intracutaneous Injection
- Cytotoxicity (MEM Elution)
- Systemic Injection
- Muscle Implantation
As the industry leader, Henkel has instituted a triennial revalidation program whereby all of our medical device adhesives are retested every three years to assure continuity of compliance.
Henkel understands the extensive resources that are committed to the qualification of a medical device, and therefore frequently consults with our medical device clients on the development of purchase specifications. A typical specification cites adhesive tests that will be met on a batch-to-batch basis and often includes a “change notification” clause. Such a partnership ensures a robust and consistent production process over the life of the medical device.
Contact us to set up a purchase specification for the Loctite brand medical device adhesive(s) that you have specified.