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

Medical Quality
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
• Hemocompatibility
• Muscle Implantation
• Physicochemical

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.

Link to ISO 10993 certificates

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 at medical.adhesives@us.henkel.com to set up a purchase specification for the Loctite brand medical device adhesive(s) that you have specified.

Medical Training
Henkel offers training programs that provide additional support to device manufacturers around the globe. Training continues after the seminar and you are linked to a network of informational sources including adhesive design guides, research data, and technical reports.

Advanced Medical Device Adhesive Workshops
These unique, fully integrated, four- to seven-hour programs are taught by Henkel engineering and technical representatives who have years of experience providing solutions to medical device manufacturers on design and assembly challenges. Presenters will review a range of issues specifically related to the medical device industry. Attendees will benefit from hands-on demonstrations of adhesives and equipment. This seminar is designed specifically for design, product and manufacturing engineers responsible for applications involving the use of adhesives.

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Onsite Technology Seminars
Henkel can customize a training program to suit your needs. Select from a menu of seven of the most requested medical device adhesive topics or request a customized seminar to meet your specific requirements. The course will be presented onsite and will include instruction, hands-on demos, samples and technical guides. Call 1-800-LOCTITE to request an on-site medical technology seminar.

Available Topics Include:

New Technologies

Light Cure Adhesives and Curing Equipment

Instant Adhesives

Epoxies (Heat Cure and 2-Part)

Silicones/Polyurethanes

Plastic/Adhesive Selection (How to Select Optimal Plastic/Adhesive Combinations)

Joint Design (How to Optimize Adhesive Joints and Avoid Poor Design)

Adhesive Biocompatibility Testing (Loctite ISO-10993 vs. USP Class VI Test Program)

Key Selection Criteria (Consideration of Uncured, Curing, and Cured Properties)

Sterilization Resistance (Sterilization methods as they relate to adhesive type)

Needle Bonding (Review of Needle Bonding Guide)

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