Regulatory & Quality Compliance

3B Medical earns trust with customers, patients, healthcare professionals, authorities and the public by acting in an honest and fair manner in all aspects of its operations. We expect the same from those with whom we do business, including distributors and independent agents that sell our products, as well as vendors that interact with others on our behalf. Our Code of Conduct and Business Principles (‘Code’) governs the way we operate to achieve these objectives.

3B Medical takes into account ethical, social, environmental, legal and financial considerations as part of its operating methods. We have a robust whistle-blowing system in all jurisdictions in which 3B Medical operates. We are committed to upholding our promise in our Code that we will not retaliate against anyone who makes a report in good faith. 3B Medical, is committed to comply with all authorities like FDA, EPA, EU, CSA to ensure that our products are in compliance with the required regulations in every country around the world.

3B Medical is implementing a robust quality management system ISO 13485, to control every aspect during all stages starting from product concept, design, testing, marketing, packaging and after sales services. 3B Medical, has established a complete system to control outsourcing suppliers and audit their processes and procedures.

New employees receive training on our Code, Quality Policies, and we assign annual compliance training to employees.

Distributors and Agents Compliance Program

In many regions, we rely on distributors and agents to do business on our behalf. They play a vital role for us and in doing so, must comply with applicable laws and industry
codes, and adhere to business principles and health, safety, social and environmental standards consistent with our own. We select third party sellers based on their qualifications, reliability, adherence to applicable laws and our values. We have a comprehensive third-party seller process which includes due diligence forms and checks, monitoring and auditing, and compliance reviews.

We never authorize any third party to act improperly on our behalf, and we have programs in place to help identify any improper behavior by third parties.