Class I and II medical devices brochure
Retail outlets are becoming more and more involved and integrated into the health and wellness space. As this market continues to grow and evolve, we are at the forefront to provide compliance and safety testing for wellness products, devices, equipment and facilities. Furthermore, UL Marketing Claim Verification and the UL Verified Mark help retailers stand out among the clutter of marketing claims.
Health and wellness retailers have many concerns when it comes to consumer and patient safety. As store systems, devices and equipment become connected, facilities become more vulnerable. Furthermore, navigating through the complexities of ever-changing regulations around the world raises concerns from retailers and consumers alike about the safety and quality of wellness products.
Cybersecurity risk management
We offer cybersecurity risk management solutions to protect patient data. Our UL Cybersecurity Assurance Program (UL CAP) for Network Connectable Components of Healthcare and Wellness Systems is used to detect unauthorized access. The CAP program is based on the following standards:
- UL 2900-1:2017 Software Cybersecurity for Network-Connectable Products, Part 1
- UL 2900-2-1:2017 Software Cybersecurity for Network-Connectable Products, Part 2-1
Class I and Class II medical devices and dietary supplement testing
We offer a complete portfolio of services for Class I and Class II medical devices and dietary supplements, including quality assurance solutions, regulatory compliance testing and global market access programs. Our team of experts lead the field in developing industry standards and test methods to help retailers develop and strengthen global compliance programs for consumer wellness products that include items such as packaging and labels, quality assessments and performance testing.
Our quality assurance solutions for dietary supplements include testing the purity and potency of raw ingredients and finished products, independent accredited audits, and quality inspections to help achieve current Good Manufacturing Practice (cGMP) compliance. This includes:
- Product specification development
- Standard operating procedure development and implementation
- Regulatory label reviews
- Supplement testing for purity/potency and contaminants for regulatory compliance
- Benchmarking analysis
In the face of increased scrutiny on what goes inside dietary supplements, the UL Verified Mark helps give consumers the assurance and trust they seek in retail products. Inside our FDA-registered U.S. laboratory, we apply scientific methodologies to verify the truth of active ingredients present in dietary supplements, as well as employ comprehensive quality test processes to identify the presence of harmful microorganisms. You can communicate truth and transparency on your product labels through our Marketing Claim Verification program to give consumers greater peace of mind.
Our services can help minimize the difficulties dealing in the over-the-counter (OTC) drug dispensary market. We provide safety testing for lab and dispensary equipment for OTC drugs.
We take into consideration many regulations and standard entities, including the FDA, when conducting safety and certification tests. We also offer quality assurance programs that evaluate your entire operation and can provide facility inspections and training. All of our health and wellness retail programs are designed with consumer and patient safety and well-being at the forefront.
Why UL Solutions
- We operate in more than 100 countries, and our reports and certifications are recognized and accepted around the world.
- We have helped to set more than 1,600 Standards defining safety, security, quality and sustainability.
- Our Marks appear on more than 22 billion products globally.
- We have an FDA-recognized consensus Standard, UL 2900, for cybersecurity.
- We deliver tailored testing solutions, using software automation to enhance process efficiency, analyze results and reduce testing cycles.
- Our Marketing Claim Verification and UL Verified Mark help you gain a business advantage by communicating facts to your buyers and confirming your marketing claims through objective, third-party evaluations.